WO2020208659A1

WO2020208659A1 - Anti-viral anti-bacterial immunoboosting composition of herbal extracts in synergistic ratios

Info

Publication number: WO2020208659A1
Application number: PCT/IN2020/050448
Authority: WO
Inventors: Rajesh Biswas; Kakoli Biswas; Parikshit Bansal; Chaitanya Marwaha
Original assignee: Rajesh Biswas; Kakoli Biswas; Parikshit Bansal; Chaitanya Marwaha
Priority date: 2020-04-19
Filing date: 2020-05-19
Publication date: 2020-10-15

Abstract

Present invention discloses an Anti-Viral Anti-Bacterial Immunoboosting single composition consisting of standardized alcoholic extracts of seven specific herbs, combined together in specific synergistic ratios as - Curcuma longa (95% Curcumim) 26-31%; Boswellia serrata resin (65% Boswellic acid)- 22-27%; Moringa pterygosperma (leaves) - 18-23%; Ocimum sanctum (leaves) -7-12%; Tinospora cordifolia (stem) - 7-12%; Withania somnifera (leaves)- 5-7%; Piper nigrum fruit (95% Piperine)- 1-2%. The invention addresses the problem of internal and external infections caused by a wide variety of viruses and bacteria in humans as well as livestock, in a holistic manner and eliminates the need for separate antivirals and antibiotics. It has both prophylactic and therapeutic applications and offers quick, effective treatment without side-effects. Owing to its unique three pronged action – anti-viral, anti-bacterial and immunoboosting, the composition offers a convenient and standardized therapy for mass use during epidemics and pandemics caused due to respiratory tract infections.

Description

ANTI VIRAL ANTI BACTERIAL IMMUNOBOOSTING COMPOSITION OF HERBAL EXTRACTS IN SYNERGISTIC RATIOS

FIELD OF INVENTION

The field of invention relates to herbal medicines. More specifically it relates to“Anti-Viral Anti-Bacterial Immunoboosting Composition of Herbal Extracts in Synergistic Ratios”.

BACKGROUND OF THE INVENTION

External and internal infections caused by viruses and bacteria are majorly responsible for the spread of diseases in humans and animals and also life threatening infections during trauma e.g. accidents, injuries. A variety of skin infections caused by bacteria and viruses are well- documented in standard medical texts. Bacteria and viruses cause infection of wounds and trauma injuries and are responsible for immense losses in case of livestock also. Common Cold and Flu are the two most common respiratory diseases caused by viruses. Bacteria also cause infections of the respiratory tract in addition to viruses, making diagnosis and treatment of respiratory infections tough and at times expensive. Viral and bacterial respiratory infections spread through air e.g. coughing and sneezing and can lead to widespread epidemics and pandemics, as in case of present pandemic termed as Covid-19.

Immuno-compromised individuals e.g. those suffering from HIV or cancer patients undergoing chemotherapy/radiotherapy, patients who have undergone organ transplant e.g. kidney transplant and are on immunosuppressant drugs, are more prone to viral and bacterial infections. Livestock reared for meat are also prone to respiratory infections e.g. poultry, pigs, sheep, goat, cattle, fish etc. Such infections can travel from animals to humans consuming such meat and lead to mass spread amongst humans i.e. epidemics and pandemics.

Introduction to present invention

Present invention discloses an Anti-Viral Anti-Bacterial Immunoboosting composition consisting of standardized commercially available alcoholic extracts of seven specific herbs, combined together in specific synergistic ratios as - Curcuma longa (95% Curcumim) 26-31%; Boswellia serrata resin (65% Boswellic acid)- 22-27%; Moringa pterygosperma ( leaves ) - 18-23%; Ocimum sanctum ( leaves ) -7-12%; Tinospora cordifolia (stem) - 7-12%; Withania somnifera (leaves)- 5-7%; Piper nigrum fruit (95% Piperine)- 1-2%. The invention addresses the problem of internal and external infections caused by a wide variety of viruses and bacteria, in a holistic manner. The standardized alcoholic extracts of various herbal ingredients are combined together synergistically in a single dosage form e.g. oral, topical or injectable or any other suitable pharmaceutical dosage form for easy and convenient therapeutic application, thus eliminating the need for separate antivirals and antibiotics. It has both prophylactic and therapeutic applications i.e. it can be useful in preventing infections if given on regular basis and in case of infected subjects, offers a quick, effective treatment without side-effects.

Owing to its unique three pronged action - anti-viral, anti-bacterial and immunoboosting, the composition offers a convenient and standardized therapy for mass use during epidemics and pandemics caused due to respiratory tract infections. The composition is a boon for patients with compromised immunity e.g. HIV patients, cancer patients undergoing chemotherapy/radiotherapy and also patients of organ transplantation who are on immunosuppressant drugs to prevent rejection of the organ. The fact that the composition is free from the side-effects commonly associated with synthetic antibiotics e.g. acidity, upset stomach, loss of appetite etc. increases the value of the invention for such patients. Livestock reared for meat are also prone to respiratory infections e.g. poultry, pigs, sheep, goat, cattle, fish etc. in which the infection can travel to humans consuming such meat and lead to mass spread i.e. epidemic and pandemic. Hence, the composition is of importance in safely treating mass infections of livestock and ensuring safe meat for human consumption or consumption of other animals as ingredient of feed.

Appropriate dosages of the composition for treatment of various external and internal infections will obviously differ depending upon extent of infection, body weight of individuals and whether the composition is being used in humans or livestock. Same can be easily worked out by those skilled in the art and shall be construed as being within the scope of present invention. Problem solved by present invention

The present invention addresses the overall problem of viral and bacterial infections including highly contagious viral infections (e.g. flu, common cold, sore throat etc.) in a single dosage form simultaneously and in a very holistic manner, covering a very wide spectrum of viruses and bacteria. Need for separate antivirals and antibiotics is thus eliminated. Owing to its unique three pronged action - anti-viral, anti-bacterial and immunoboosting IN A SINGLE DOSAGE FORM, the composition offers a convenient and standardized therapy for mass use during epidemics and pandemics caused due to respiratory tract infections. It is especially useful for patients suffering from such infections e.g. in case of epidemics or pandemics.

Advantages of Present Invention

i. Holistic broad spectrum action against viral and/or bacterial infections- This leads to widespread practical application in prevention and treatment of internal and external infections of humans and livestock including fish and aquatic animals., caused by viruses and bacteria.

ii. Powerful therapeutic efficacy in single defined dose - Three pronged action i.e. anti-viral, anti-bacterial and immunobooster is obtained in a single dosage form, making application and patient compliance very easy e.g. MASS USE IN EPIDEMICS AND PANDEMICS. iii. Safety - Ingredients used in the composition are herbs already in use as food or medicine, making its use overall safe and without any side-effects.

iv. Need for separate antivirals and antibiotics eliminated- Single dosage form with dual antiviral and antibacterial effect, due to which no need for separate antivirals and antibiotics. v. Ideal for patients with compromised immunity - e.g. HIV patients, cancer patients undergoing chemotherapy/radiotherapy and also patients of organ transplantation who are on immunosuppressant drugs to prevent rejection of the organ. The fact that the composition is free from the side-effects commonly associated with synthetic antibiotics e.g. acidity, upset stomach, loss of appetite etc. increases the value of the invention for such patients. vi. Bacterial or viral resistance is not possible in present composition - This is because there is no single purified compound present in it, unlike in synthetic antibiotics and antivirals. vii. No side-effects - Unlike anti-viral drugs and antibiotics which have side-effects, the composition is free from any side effects at all.

Two most common respiratory diseases caused by viruses and bacteria- Cold and Flu

Common Cold and Flu are the two most common respiratory diseases caused by viruses. Bacteria also cause infections of the respiratory tract in addition to viruses, making diagnosis and treatment of respiratory infections tough and at times expensive. Viral infections cause immense economic loss and loss of lives worldwide on annual basis.

Seasonal influenza spreads all over the world as an annual outbreak, causing about 3-5 million severe illness cases and about 250,000 to 500,000 death cases. In USA, annual economic burden due to seasonal influenza is approximately more than US $1 billion or Rs. 7500 crores (https://www.hindawi.com/joumals/jam/2017/4264737/). Repeated annual outbreaks clearly show that existing medicines are ineffective to tackle the menace and there is a dire need for an innovative, low-cost approach. COVID-19 disease is a case in point, in which several patients have died worldwide and economic loss is beyond calculation. Important Facts Regarding Cold and Flu

Common Cold and Flu are caused by viruses and infect millions of people worldwide, every year. They cannot be treated with antibiotics because antibiotics don’t work against viruses.

Flu is more severe than common cold and if left untreated, can lead to hospitalization in some cases. Table 1 below compares the symptoms of Cold and Flu.

Table 1: Common Cold vs. Flu

(Ref: Centers for Disease Control and Prevention, USA;

www.cdc.gov/flu/symptoms/coldflu.htm)

Viruses Causing Common Cold

There are more than 200 viruses which cause common cold, due to which a single‘anti-cold’ vaccine is not possible. Even existing viruses keep on mutating and are not stable. Viruses causing common cold are rhinovirus which is responsible for upto 80% colds during peak season and 30%-40% of all adult colds. Other cold causing viruses include coronavirus, adenovirus, respiratory syncytial virus and parainfluenza virus. This is the reason why common cold remains ‘uncontrolled’ and occurs several times a year globally. https://www.medicinenet.com/common_cold/article.htm ).

( Turner , Ronald B. "Rhinovirus: More than Just a Common Cold Virus. " The Journal of

Infectious Diseases 195.6 Mar. 15, 2007: 765-766. https://doi.org/10.1086/511829; United States. Centers for Disease Control and Prevention (CDC). "Common Cold and Runny Nose.” Sept. 26, 2017. <https://www.cdc.gov/antibiotic-use/community/for-patients/common- illnesses/colds.html> .; United States. Centers for Disease Control and Prevention (CDC). "Common Colds: Protect Yourself and Others.” Feb. 12, 2018. https://www.cdc.gov/features/rhinoviruses/. )

Coronaviruses - A Category of Harmless Cold Causing Viruses which on mutation cause outbreak of Respiratory diseases including Present Covid-19 disease Coronaviruses are a category of harmless, common cold causing RNA viruses found throughout the world. They account for up to 30 percent of upper respiratory tract infections in adults and are named“corona” (like a crown) because their membranes are studded by spike-like proteins. They are‘zoonotic’, meaning they can spread from animals to humans and take more virulent forms.

In past 20 years, two coronavirus outbreaks arising from bat-to-human transmission have taken place- severe acute respiratory syndrome (SARS) in 2002 and Middle East respiratory syndrome (MERS) in 2012. Both SARS and MERS had higher mortality rates than COVID-19 but spread through human-human transmission more slowly. Outbreak of COVID-19 marks the third time in recent years that a coronavirus has emerged to cause severe disease and death in some people. Soon after COVID-19 emerged, the new coronavirus, which is closely related to SARS, was recognized as its cause.

(https://www.jax.org/coronavirus; https://directorsblog.nih.gov/2020/03/03/structural-biology- points-way-to-coronavirus-vaccine/; Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Wrapp D, Wang N, Corbett KS, Goldsmith JA, Hsieh CL, Abiona O, Graham BS, McLellan JS. Science. 2020 Feb 19; A new coronavirus associated with human respiratory disease in China. Wu F et al. Nature. 2020 Feb 3; NIH clinical trial of remdesivir to treat COVID-19 begins. NIH News Release. Feb 25, 2020). Epidemics in the past caused by Corona viruses and some interesting facts relating to the same are given in Table 2 below:

Table 2: Disease Outbreaks Caused by Human Coronaviruses

Influenza Viruses are the Viruses responsible for causing Flu

Flu is specifically caused by‘Influenza Viruses’ which are of 4 types viz. A, B, C and D.

Influenza virus subtypes are distinguished based upon the antigenic properties of two surface glycoproteins: hemagglutinin (H) and neuraminidase (N), which promote and coordinate host cell entry and exit, respectively.

Influenza viruses are very simple in structure— consisting of a protein shell surrounding a tiny extract of genetic material. An infected cell inadvertently reads this extract of genetic material as its own, blindly following these instructions to build thousands of new viruses. In addition, the influenza virus has two surface glycoproteins that represent its main tools for infecting cells.

One of these glycoproteins is a neuraminase , meaning that it breaks down neuraminic

acid— an important component of sputum. The NA allows viruses to disperse through thick respiratory secretions and therefore infect more cells. Drugs such as Relenza® (zanamivir) and Tamiflu® (oseltamivir phosphate) inhibit the action of neuraminase, and therefore impair the ability of the virus to spread.

The second of these glycoproteins is a hemagluttinin, so named because it causes red cells to stick together when added to blood. Hemagluttinin is the influenza virus' principal means of infection, for this protein allows the virus to bind to sialic acid on a cell's surface, and mechanically inserts the genetic material into the cell. The influenza virus infects a number of animals including humans, pigs and birds— and demonstrates the ability to create different combinations of H, N and protein shell subtypes, particularly when a cell is co-infected with different viruses. For example, a cell infected with both an H1N1 and H5N3 virus may create new H5N1 viruses. The H5N1 combination has proven to be highly lethal in birds, creating concern that exchanging the H5 protein into a human influenza virus could result in a disastrous pandemic. The influenza A viruses associated with conditions such as avian flu are known to have hemagglutinin (HA) and neuraminidase (NA) membrane glycoproteins. The HA functions as the receptor binding and membrane fusion glycoprotein in cell entry and the NA functions as the receptor-destroying enzyme in virus release. According to some sources, there are fifteen subtypes of HA (HI -HI 5) that share between 40% and 60% sequence identity. Similarly, nine NA (N1-N9) subtypes have been identified with between 40% and 60% sequence identity. HI, H2, and/or H3 have been identified in humans in viruses causing pandemics in 1918, 1957, 1968, and 1977.

Viruses containing H5 and H9 have been found in humans infected with influenza in Hong Kong and China in the late 1990's.

Viruses containing all 15 HA subtypes have been found in avian species. Additional detail about the history, structure, and characteristics of the influenza virus are found at Ha et al., X-ray structure of H5 avian and H9 swine influenza virus hemagluttinins bound to avian and human receptor analogs (PNAS, vol. 98, no. 20, pp. 11181-11186, Sep. 25, 2001, www.pnas.org/cgi/doi/10.1073/pnas.201401198); Ha et al), H5 avian and H9 swine influenza virus haemagglutinin structures: possible origins of influenza subtypes (The European Molecular Biology Organization Journal, Vol. 21, No. 5, pp. 865-875 (2002; Cross et al.), Mechanism of Cell Entry by Influenza Virus ( Expert Reviews in Molecular Medicine, pp. 1-18, Aug. 6, 2001, http://www ermm.cbcu.cam.ac.uk/01003453h.htm); and Whittaker, Intracellular trafficking of influenza virus: clinical implications for molecular medicine ( Expert Reviews in Molecular Medicine, Feb. 8, 2001, http://www ermm.cbcu.cam.ac.uk/01002447h.htm ).

The HA portion of the virus has two functions, receptor binding to the cell and membrane fusion to the cell. The HA binding is similar in the avian virus and the human virus. The human virus prefers terminal sialic acids of glycoproteins and glycolipid receptors in alpha 2, 6 linkage to galactose while the avian virus prefers alpha 2, 3 linkages to galactose. The human lung and airway epithelial cells have an abundance of alpha 2, 6 linkages. Moreover, the human lungs have potentially inhibitory mucins rich in alpha 2, 3 linages. A paper by Ha et al. ( PNAS , vol. 98, no. 20, pp. 11181-11186, Sep. 25, 2001, www.pnas.org/cgi/doi/10.1073/pnas.201401198) suggests that the receptor binding sites of human and avian HA differs with the human binding site being wider and favoring alpha 2, 6 linkages while the avian binding site is narrower and favors alpha 2, 3 linkages. Reports in the scientific literature state that all fifteen HA subtypes fall within four major structural classes by correlating differences in the relative positions of subdomains in the H3, H5, and H9 HAs. {Ref: US20080000473A1 ) Influenza viruses are classified into various subtypes

The United States Centers for Disease Control and Prevention identifies 18 H subtypes and 11 N subtypes, for a theoretical total of 198 strain variations ( Centers for Disease Control and Prevention Types of Influenza Viruses http://www.cdc.gov/flu/about/viruses/types.htm). However, only HI, H2, and H3 are known to have achieved substantial human-to-human transmission {Webby R., Webster R. Are we ready for pandemic influenza? Science. 2003; 302:1519 1522. doi: 10.1126/science.l090350).

How do influenza viruses cause pandemics?

By mutations. Flu in humans is caused by A and B types only. While types A and B are responsible for the majority of morbidity and mortality, type A is the only one with pandemic potential. This is because type A is the only strain with an animal reservoir. Aquatic birds and swine are important reservoirs for influenza A, presenting obstacles to eradication and providing opportunities for viral mutation and re-assortment. The highly variable nature of influenza genetic material prevents maintenance of an adequate immune response acquired from previous infections, leading to annual epidemics of“seasonal influenza”. Within the past one hundred years, four pandemics have resulted from the emergence of a novel influenza strain as given in Table 3 below:

Table 3: Epidemics in the world caused by Influenza Viruses

(Ref: Saunders-Hastings PR, Krewski D. Reviewing the History of Pandemic Influenza:

Understanding Patterns of Emergence and Transmission. Pathogens (Basel, Switzerland). 2016 Dec; 5(4) DOI: 10.3390/pathogens5040066.)

Of the eight genes in the influenza 2009 A (H1N1) strain causing the 2009 human pandemic:

• PA, PB2 were swine genes that originated in birds (a triple reassortant strain)

• PB 1 is a swine gene that passed from birds to humans then swine (a triple reassortant) · HA, NP, NS are swine genes that originated in birds (classical swine virus/triple reassortant).

• NA, M are Eurasian swine genes that originated in birds (Eurasian swine influenza virus).

Thus, mixing took place in‘birds’,‘humans’,‘swine’ and transmission between bird to bird, bird to human, human to swine, swine to bird and so on, resulting in a‘cocktail’ that was lethal to humans.

Existing Approaches for the Prevention and Treatment of Viral Respiratory Infections · Immunity Boosting - Common cold is best treated by resting and allowing the body’s own immunity to cope with it. Immunity boosters can help in recovery. Vitamins critical for immune function include vitamins A, C, D, and E. Zinc, selenium, and magnesium are minerals that boost the immune system. These minerals are also critical for the function of many enzyme reactions in the body. • Vaccines- Vaccines represent a powerful tool for preventing flu, but will not work in case viruses mutate or flu is caused by viruses other than those used in the vaccine preparation.

• Anti-viral drugs - For adults hospitalized with flu illness, some studies have reported that early antiviral treatment can reduce their risk of death. The Centers for Disease Control and Prevention, USA (CDC) recommends four FDA approved drugs for treatment of flu viz. oral oseltamivir phosphate (trade name Tamiflu®); inhaled zanamivir (trade name Relenza®) for inhalation; IV injected peramivir (trade name Rapivab®) and single dose oral baloxavir marboxil (trade name Xofluza®). Oseltamivir and zanamivir are usually prescribed to be taken twice daily for 5 days, although people hospitalized with flu may need antiviral treatment for longer than 5 days. Peramivir is administered one time intravenously over a period of 15 to 30 minutes providing an alternative access to patients unable to take medication via the oral (oseltamivir) or inhalation (zanamivir) routes. Baloxavir is given as a single oral dose.

(https://www.cdc.gov/flu/treatment/whatyoushould.htm).

The mode of action of these drugs is given in Table 4 below:

TABLE 4: US FDA Approved anti-viral drugs against Flu and their mode of action

endonuclease activity. Stops viral replication. ⁴

1. Davies B. E. (2010). Pharmacokinetics of oseltamivir: an oral antiviral for the treatment and prophylaxis of influenza in diverse populations. The Journal of antimicrobial chemotherapy, 65 Suppl 2 (Suppl 2), H5 iilO. https://doi.org/10.1093/jac/dkq015

2. https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/zanamivir

3. Alame, M. M., Massaad, E., & Zaraket, H. (2016). Peramivir: A Novel Intravenous

Neuraminidase Inhibitor for Treatment of Acute Influenza Infections. Frontiers in microbiology, 7, 450

4. https://www.xofl.uza. com/hcp/why-xofluza/mechanism-of-action. html

Failure of anti-flu vaccines and synthetic anti-viral drugs is due to mutations in viruses caused by antigenic drift and re-assortment

Antigenic drift- Anti-flu vaccines and drugs at times fail, due to mutations or‘change in structure’ of the viruses. Like all living things, influenza virus makes small errors— mutations— when it copies its genetic code during reproduction. But influenza lacks the ability to repair those errors, because it is an RNA virus; RNA, unlike DNA, lacks a self-correcting mechanism. As a result, influenza is not genetically stable. Every generation is slightly different, and those differences accumulate as time passes. That slow deviation is called antigenic drift, and it is the reason why it is necessary to reformulate flu vaccines every year.

(https://nieman.harvard.edu/wp-content/uploads/pod-assets/microsites/ Nieman Guide To Covering Pandemic Flu /The Science/HowFluVirusesChange.aspx.html).

Every flu season, the genetic make-up of the dominant strains from the prior year will have drifted, changing the surface structure of those strains just enough to diminish, or even destroy, the effectiveness of the previous year’s vaccine. Each winter, health authorities must make an educated guess which strains are likely to dominate in the next flu season. It takes six more months to develop and manufacture vaccines for chosen strains. But in some years, genetic drift during just those six months can render the newly formulated vaccine ineffective, leaving populations more vulnerable to the newly evolved virus.“Antigenic” refers to proteins on the virus’s surface that allow the virus to infect its host and that cause the host’s immune system to react. Antigenic drift can occur in all three types of influenza: A, B, and C. Antigenic drift is slow and moderately predictable: Researchers understand the rate at which flu changes, though they cannot predict how different the final product will be.

Re-assortment- Flu can also change rapidly, due not to mutation, but to what is called a“genetic exchange event,” in which flu viruses in close proximity swap entire sections of their genetic code e.g. when different populations coexist in multiple susceptible mammalian hosts (humans, pigs, cats), there is an increased likelihood of“Genetic-exchange events” resulting in making of new pandemic strains. Change in the efficiency of human-to-human transmission is a major factor in turning an epidemic strain into a pandemic one ( Mark S. Klempner, Daniel S. Shapiro, “Crossing the Species Barrier One Small Step to Man, One Giant Leap to Mankind,” New England Journal of Medicine 350:12 ( March 18, 2004): 1171-1172 ). Two influenza A strains can infect animals simultaneously and combine to form a new virus that contains a mixture of the genes of the two original strains. This can also happen in people infected with two strains at the same time although birds and swine are considered the major“mixing vessels.” New influenza types emerge from such unpredictable recombination— reassortment— events between human and mammalian or avian viruses. These events occur at irregular intervals (K. Stohr, “Influenza,” Control of Communicable Diseases Manual, ed. David L. Heymann (Washington, DC: American Public Health Association, 2004)). If the new virus causes illness in people and can be transmitted easily from person to person, then the virus has the potential to cause an epidemic or pandemic (Centers for Disease Control and Prevention, Transmission of Influenza A Viruses Between Animals and People, Oct. 17, 2005).

Re-assortment can create entirely new and possibly very lethal viruses

Reassortment can produce major changes in the influenza virus and represents a significant way for viruses to evolve and create a new pandemic strain. Influenza’s genome is made up of eight loosely linked segments, each of which harbors at least one important gene. Those genes direct the expression of influenza’s major viral proteins including hemagglutinin and neuraminadase, the antigenic proteins on the viral surface that that foster infection and stimulate immune reaction. When flu viruses infect cells to reproduce, they use the cell’s molecular machinery to manufacture individual virus components including more viral RNA and proteins, and package them into new viruses that bud off of the cell. In the process of reproduction, the linkages between the segments of the flu genome break apart, leaving the segments free. If the virus happens to have infected a cell that is simultaneously being infected by a flu virus of another strain, then the possibility exists that some of the genetic segments from those strains will be swapped in the process of reproduction. For instance, if a human H3N2 flu virus and a bird H7N3 flu virus infect a person, reassortment can intermingle genes from both viruses during replication ( Centers for Disease Control and Prevention, Transmission of Influenza A Viruses between Animals and People, Oct. 17, 2005). Because more than one virus is being produced in the infected cell, new viral copies could have a hemagglutinin (H7) from the avian virus and neuraminidase (H2) gene from the human virus making a reassortant flu virus, H7N2 that is different from the two original viruses. The significance of these events is that they create influenza A viruses with different properties from the original infecting strains. The reassortant virus could, for instance, possess an avian hemagglutinin (H) protein against which humans have little or no immunity plus human influenza genes that are more likely to cause sustained human- to-human transmission. The net result could be a new strain that has pandemic potential. Other types of re-assortment events can shuffle individual viral genes. Because flu’s genome has eight segments, the potential number of different viral progeny can be as great as 256 types. Much of this information comes from the ability to sequence viral genetic material and compare sequences between different viruses.

Pandemics from reassorted viruses

Reassortment among subtypes from avian and human viruses were important in producing new strains that caused the 1957 (H2N2 subtype) and 1968 (H3N2 subtype) human influenza pandemics. Multiple reassortment events are also possible and have prompted concerns about the creation of new viruses. Researchers had thought that only the H and N gene were switched during reassortment. Recent analyses of influenza genetic material suggest that multiple genes can be recombined. Several investigators have found influenza viruses that arose from triple reassortment events among swine ( Jon Cohen, “New Details on Virus's Promiscuous Past,” Science 324 ( May 29, 2009): 1127). Genetic sequence analysis of many viral subtypes suggested that the 2009 pandemic swine influenza virus arose from a reassortment event between a triple reassortant influenza virus containing human, swine, and avian influenza genes and a Eurasian swine influenza virus ( Rebecca J Garten, C. Todd Davis, Colin A. Russell, et. ah, “Antigenic and Genetic Characteristics of Swine-Origin 2009 A (HlNl ) Influenza Viruses Circulating in Humans,” Science 325 (July 10, 2009): 197-201).

Mutation in viruses is a Natural Phenomenon beyond human control

From the above discussions, it is very clear that the mutation and change in structure of viruses (which cause respiratory diseases e.g. cold, flu etc.) is a natural phenomenon and cannot be prevented. This underlines the need for a radically different approach to tackle the menace of respiratory infections caused by viruses, which affect people worldwide, since existing approaches have failed. This is evident from the pandemic of 2019-20 caused by SARS-CoV-2 virus leading to Covid-19 disease. Respiratory infections are caused by Bacteria also and not viruses alone

About 90% of infections in cold and flu are due to viruses. However, bacterial infections can also take place, leading to sore throat (pharyngitis also called tonsillitis because it leads to inflammation of the tonsils). In cases of infectious pharyngitis that are not viral, the cause is almost always a bacterium— usually a group A beta-hemolytic Streptococcus, which causes what is commonly called strep throat. Like viral pharyngitis, strep throat can spread quickly and easily within a community, especially during late winter and early spring. Bacterial infections are treated by prescribing antibiotics such as penicillin or amoxicillin to eliminate the strep bacteria and in case one is allergic to these, other macrolides, such as azithromycin (Zithromax) can be prescribed. (https://wwwJieahh.harvard.edU/a to z/sore-throat-pharyngiiis-a-to-z). Treatment of Respiratory Infections caused by Bacteria - Use of Antibiotics

Existing approach to the treatment of respiratory infections caused by bacteria, involves use of broad-spectrum antibiotics. A broad- spectrum antibiotic is an antibiotic that acts on the two major bacterial groups, gram-positive and gram-negative, or any antibiotic that acts against a wide range of disease-causing bacteria. These medications are used in the following situations: i. Empirically- when the causative organism is unknown, but delays in treatment would lead to worsening infection or spread of bacteria to other parts of the body. This occurs, for example, in meningitis, where the patient can become fatally ill within hours if broad-spectrum antibiotics are not initiated.

ii. For drug-resistant bacteria - that do not respond to narrow-spectrum antibiotics. iii. In the case of superinfections - where there are multiple types of bacteria causing illness, thus warranting either a broad-spectrum antibiotic or combination antibiotic therapy.

iv. For prophylaxis -in order to prevent bacterial infections occurring. For example, this can occur before surgery, to prevent infection during the operation, or for patients with immunosuppression who are at high-risk for dangerous bacterial infections.

Examples of top ten commonly used broad spectrum antibiotics are ampicillin. amoxicillin, doxycycline, cephalexin, ciprofloxacin, clindamycin, metronidazole, azithromycin, sulfamethoxazole and trimethoprim; amoxicillin and clavulanate; and levofloxacin.

(Ref:https://en.wikipedia.org/wiki/Broad-spectrum_antibiotic;

htps://www.drugs.com/article/antibiotics.html)

Side-effects of antivirals and antibiotics- Both antibiotics and antivirals are associated with side effects as given in Table 5 below:

Table 5: Side effects of Antiviral Drugs and Antibiotics

( Ref: www.cdc.gov/flu/treatment/whatyoushould.htm; https://www.cdc.gov/antibiotic-use/community/pdfs/aaw/AU_Do-antibiotics-have-side- infographic_8_5x5_5_2_508.pdf)

Limitations of existing methods for the treatment of respiratory infections caused by viruses or bacteria or both

i. Anti-viral approaches fail due to appearance of new viruses produced by mutations - Vaccines and anti-viral drugs fail when viruses mutate and novel strains are generated. This is evident in present times when a new strain of coronavirus has caused Covid-19 pandemic across the world rendering existing vaccines and anti-viral drugs ineffective.

ii. Anti-bacterial approaches fail due to appearance of drug resistance in bacteria-

Antibiotics are rendered ineffective when bacteria mutate and become‘drug resistant’ or new strains of bacteria arise against which existing antibiotics fail

iii. Undesirable side-effects- Both anti-viral drugs and antibiotics are associated with side-effects. Fighting Nature with Nature- Innovative Approach Adopted in the present invention Mutation of viruses is a natural phenomenon

It can neither be stopped nor controlled. Mutated viruses repeatedly cause pandemics of respiratory diseases across the world, causing loss of precious lives and a blow to economies of countries. This is evident from the present Covid-19 pandemic of 2019-2020, which after several months, is still causing thousands of deaths globally and has paralyzed all economic activities. Recognizing that existing strategies of development of vaccines and drugs against viruses failed to contain outbreaks of epidemics across the world, inventors adopted new strategy of‘fighting nature with nature’.

Presence of Herbs with anti-viral, anti-bacterial and immunoboosting activity is also a natural phenomenon

A wide variety of herbs are present in nature, with potent anti-viral and anti-bacterial activities. Ganjhu et al. (2015) have extensively reviewed the anti-viral activities of plants existing in nature. (Ganjhu, R. K., Mudgal, P. P., Maity, H., Dowarha, D., Devadiga, S., Nag, S., & Arunkumar, G. (2015). Herbal plants and plant preparations as remedial approach for viral diseases. Virus disease, 26(4), 225 236. https://doi.org/10.1007/sl3337-015-0276-6)

Mukhtar et al (2007) have also extensively reviewed the anti-viral activity of plants. (Mukhtar, M., Arshad, M., Ahmad, M., Pomerantz, R. J-, Wigdahl, B., & Parveen, Z. (2008). Antiviral potentials of medicinal plants. Virus research, 131(2), 111 120. https://doi. org/10.1016/j. virus res.2007.09.008).

Supon et al. (2020) has disclosed widespread antimicrobial activity of several plants found in Sri Lanka ( Screening for bioactive secondary metabolites in Sri Lankan medicinal plants by microfractionation and targeted isolation of antimicrobial flavonoids from Derris scandens. Journal of Ethnopharmacology; Volume 246, 10 January 2020, 112158; https://doi org/10J016/j . jep.2019.112158). Use of Medicinal Plants as microbial agents, has been extensively reviewed by Namita et al. (2012) (Namita, Parmar & Mukesh, Rawat. (2012). Medicinal plants used as antimicrobial agents: A review. Int Res J P harm. 3. 31-40).

Use of plants and herbs as immunity boosting agents has been reviewed extensively by Sultan (2014). (Sultan, M. T., Butt, M. S., Qayyum, M. M., & Suleria, H. A. (2014). Immunity: plants as effective mediators. Critical reviews in food science and nutrition, 54(10), 1298 1308. https://doi.0rg/lQJO8O/l 0408398.2011.633249).

Fighting‘Nature with Nature’ approach against viruses and bacteria finds strong scientific support in published literature

Herbal plants, plant preparations and phytoconstituents have proved useful in attenuating infectious conditions and were the only remedies available, till the advent of antibiotics (many being of plant origin themselves). Among infectious diseases, viral diseases in particular, remain the leading cause of death in humans globally. Herbal sources provide researchers enormous scope to explore and bring out viable alternatives against viral diseases, considering non availability of suitable drug candidates and increasing resistance to existing drug molecules for many emerging and re-emerging viral diseases ( Ganjhu , R. K., Mudgal, P. P., Maity, H., Dowarha, D., Devadiga, S., Nag, S., & Arunkumar, G. (2015). Herbal plants and plant preparations as remedial approach for viral diseases. Virus disease, 26(4), 225 236.). Why despite so much support in global scientific literature,‘fighting nature with nature’ approach in case of epidemics/pandemics has failed to find a place in modern medicine? Why modern medicine does not accept herbals and relies only on vaccines and synthetic drugs, which fail in viral diseases during pandemics/epidemics and also suffer from side- effects?

Despite a wealth of traditional and modern scientific literature relating to the usefulness of ‘nature’ i.e. plants in fighting pandemics caused by viral diseases, there is NOT A SINGLE HERBAL MEDICINE FOR TREATMENT OF VIRAL INFECTIONS IS GLOBALLY APPROVED OR AVAILABLE, unlike synthetic anti-viral drugs which are globally approved and available.

Reasons for absence of‘herbal’ anti-viral medicines/natural antibiotics at global level

Inventors identified some of the significant reasons for the same, as below:

i. Limited raw material sources severely restricts large scale production: Use of roots or bark severely restricts availability of raw material sources. In other cases, raw material is available seasonally only. Other limitations are availability of plants only in geographical zones which necessitates imports.

ii. Lack of standardization leads to variation in clinical outcomes: Herbal medicines face the challenge of batch to batch variation, which makes approvals under the modem system of medicine very difficult and also leads to variable clinical outcomes. iii. Most of the published scientific studies relating to herbals are incomplete and do not address commercial issues: Quite often the extraction procedures for herbs and their active fractions as described in the studies are not feasible at commercial scale or not viable commercially. Further, quite a few studies relate to only in vitro data or in vivo data involving small animals i.e. pre-clinical studies, which are not pursued further by the labs. Extracts or formulations which have reached clinical stage of evaluation are thus very few.

iv. Clinical data on commercially available and approved herbal medicines is negligible: In India alone, a very large number of‘herbal formulations’ are available in the market, which are approved by the drug regulatory authorities under the Ayurvedic System. These herbal formulations are of two types viz.

a. Classical formulations - documented in the ancient Ayurvedic texts and manufactured as such, without deviating from the original formula b. Patent or Proprietary formulations- developed by Ayurvedic practitioners based on their clinical experience and observations.

There are hundreds of such formulations in India and are used by millions of patients. However, clinical data relating to their safety and efficacy is very less or missing altogether, as the system of herbals does not involve active documentation and data sharing on the scale which modern medicine does. This is in contrast to modem medicines based on‘synthetic drugs’ or molecules, in which substantial clinical data relating to safety, efficacy and side-effects is ALWAYS available.

v. Dosage and Duration is variable- Most herbal medicines do not have well-defined, standardized dosage forms, which leads to variable clinical results.

vi. Procedures for approval of natural medicines vary from country to country: India follows the‘ayurvedic’ system for approval of herbal medicines using standard texts based on ancient knowledge in which herbal compositions are documented for specific diseases and properties of herbs, methods of formulation, precautions during formulation and use etc. are elaborated. Such systems are not prevalent in other countries. There is no‘harmonized’ system for the approval of herbal drugs at global level, which facilitates the quick and easy approval of herbal dmgs. In absence of such a system, the outreach of herbal medicines suffers a big setback. Even very good medicines remain confined to ‘local use’ in a country only or even just the clinic of the doctor who is dispensing the same to his patients.

Present Invention has addressed the above problems in an innovative and holistic manner

Recognizing the challenges associated with herbal medicines, the inventors addressed the problems as below: i. Limited raw material sources- The problem was addressed by use of easily available commercial extracts, so that lack of raw material availability would not become an issue during industrial scale up.

ii. Lack of standardization: To overcome the problem, inventors focused on use of only strictly standardized, commercially available extracts in the composition. This ensured that batch to batch variation was avoided and meeting quality assurance requirements for global approvals, would be easy.

iii. Incomplete scientific studies as disclosed in publications relating to extraction methods: To overcome procurement issues of raw materials, equipment design for new processes and also research for development of commercially viable processes relating to processes as disclosed in scientific publications, inventors went in for use of ONLY SPECIFIC STANDARDIZED COMMERCIALLY AVAILABLE EXTRACTS IN THE COMPOSITION.

iv. Clinical data on commercially available and approved herbal medicines is negligible: To address this issue, the formulation was evaluated clinically by an experienced and practicing Ayurvedic Physician, using composition as ‘in-house’ formulated and dispensed medication. Clinical data recording was done in proper scientific format, to ensure assessment of efficacy of the composition, at prescribed dose as determined by the physician. Thus ‘proof of concept’ relating to efficacy and safety of the composition, in patients diagnosed with flu was generated at the very first stage, making conduct of multi-centric clinical trials under the modern system of medicine, easy.

v. Dosage and duration is variable: To address this issue, inventors did a careful review of synergy of the herbs, their compatibility and also upper safety limit of doses of individual herbs, to arrive at a single standardized adult human dosage per day. This makes dispensing and patient compliance very easy which is of particular significance in mass treatment of populations in case of enidemics and pandemics. vi. Procedures for approval of natural medicines vary from country to country: To address this issue, the inventors adopted the following strategy: - Use of only Standardized commercially available extracts: To address queries relating to how batch to batch variation will be avoided

- Use of only specific herbs in common use as food or approved as dietary supplements/medicines and whose safety profile was well-known: To address queries relating to toxicity or side-effects.

- Formulation of composition into a standard, single oral dosage form: To address issue of‘support for claims’ the composition was formulated into a well- defined, single oral dosage form, which could be evaluated scientifically as per modern analytical methods, anywhere in the world.

- Clinical evaluation as in-house formulated and dispensed medicine by qualified Ayurvedic Physician: To address issue of clinical efficacy and safety. Approval of the present composition across the world, is thus easy owing to use of well-defined extracts, dosage and duration of treatment, safety and efficacy data and total absence of any side -effects.

This innovative approach of the inventors of fighting nature (mutated viruses, bacteria, low immunity) with nature (powerful cocktail of phytochemicals present in various herbs) resulted in the synergistic combination of present invention. When evaluated clinically in patients suffering from viral and bacterial respiratory infections, the composition showed remarkable success as indicated by quick relief and absence of any side-effects at all.

Prior art

The prior art relating to herbal compositions for the treatment of respiratory diseases caused by viruses and bacteria is as below: Ganjhu et al. (2015) have extensively reviewed the anti-viral activities of plants existing in nature. (Ganjhu, R. K., Mudgal, P. P., Maity, H., Dowarha, D., Devadiga, S., Nag, S., & Arunkumar, G. (2015). Herbal plants and plant preparations as remedial approach for viral diseases. Virus disease, 26(4), 225 236. https://doi.org/10.1007/sl3337-015-0276-6) Mukhtar et al (2007) have also extensively reviewed the anti-viral activity of plants. (Mukhtar, M., Arshad, M., Ahmad, M., Pomerantz, R. J-, Wigdahl, B., & Parveen, Z. (2008). Antiviral potentials of medicinal plants. Virus research, 131(2), 111 120. https://doi. org/10.1016/j. virus res.2007.09.008).

Supon et al. (2020) has disclosed widespread antimicrobial activity of several plants found in Sri Lanka ( Screening for bioactive secondary metabolites in Sri Lankan medicinal plants by microfractionation and targeted isolation of antimicrobial flavonoids from Derris scandens. Journal of Ethnopharmacology; Volume 246, 10 January 2020, 112158; https://doi. org/10.1016/j.jep.2019.112158)

Namita et al. (2012) has extensively reviewed use of Medicinal Plants as microbial agents (Namita, Parmar & Mukesh, Rawat. (2012). Medicinal plants used as antimicrobial agents: A review. Int Res J Pharm. 3. 31-40).

Sultan (2014) has extensively reviewed plants and herbs as immunity boosting agents (Sultan, M. T., Butt, M. S., Qayyum, M. M., & Suleria, H. A. (2014). Immunity: plants as effective mediators. Critical reviews in food science and nutrition, 54(10), 1298 1308. https://doi. org/10.1080/10408398.2011.633249 )

A search of several international and Indian Patent databases did not reveal disclosure of any composition as disclosed in the present invention.

From the above it is clear that none of the prior art discloses or anticipates the composition of present invention. Though anti-viral activity, antibacterial activity and also immunoboosting activity of several herbs is disclosed in literature in a fragmented manner by researchers from several countries across the world. A SINGLE COMPOSITION WITH THREE PRONGED ACTION OF ANTI-VIRAL, ANTI-BACTERIAL AND IMMUNOBOOSTING PROPERTIES, AS DISCLOSED IN PRESENT INVENTION HAS NOT BEEN DISCLOSED ANYWHERE IN THE PRIOR ART.

OBJECTS OF THE PRESENT INVENTION

In general it is an object of the invention to disclose an Anti-Viral Anti-Bacterial Immunoboosting Composition of Herbal Extracts in Synergistic Ratios for treating internal and external infections in humans and livestock and also for prophylactic use. Another object of the invention to disclose its method of preparation.

A further object is to disclose the dosage and duration of use of the said composition for treatment of respiratory infections.

1. Yet another object of the invention is to disclose that the composition is without any side- effects.

SUMMARY OF THE INVENTION

Present invention discloses an Anti-Viral Anti-Bacterial Immunoboosting single composition consisting of standardized commercially available alcoholic extracts of seven specific herbs, combined together in specific synergistic ratios as - Curcuma longa (95% Curcumin) 26-31%; Boswellia serrata resin (65% Boswellic acid)- 22-27%; Moringa pterygosperma (leaves) - 18- 23%; Ocimum sanctum (leaves) -7-12%; Tinospora cordifolia (stem) - 7-12%; Withania somnifera (leaves)- 5-7%; Piper nigrum fruit (95% Piperine)- 1-2%. The invention addresses the problem of internal and external infections caused by a wide variety of viruses and bacteria in a holistic manner. The extracts of various herbal ingredients are combined together synergistically in a single dosage form e.g. oral, topical or injectable or any other suitable pharmaceutical dosage form for easy and convenient therapeutic application, thus eliminating the need for separate antivirals, antibiotics and immunoboosters. The composition has both prophylactic and therapeutic applications i.e. it can be useful in preventing infections if given on regular basis and in case of infected subjects, offers a quick, effective treatment without side- effects. Owing to its unique three pronged action - anti-viral, anti-bacterial and immunoboosting, the composition offers a convenient and standardized therapy for mass use during epidemics and pandemics caused due to respiratory tract infections (different types of Flu).

The composition is a boon for patients with compromised immunity e.g. HIV patients, cancer patients undergoing chemotherapy/radiotherapy and also patients of organ transplantation who are on immunosuppressant drugs to prevent rejection of the organ. The fact that the composition is free from the side-effects commonly associated with synthetic antibiotics e.g. acidity, upset stomach, loss of appetite etc. increases the value of the invention for such patients. Livestock reared for meat are also prone to respiratory infections e.g. poultry, pigs, sheep, goat, cattle, fish etc. in which the infection can travel to humans consuming such meat and lead to mass spread i.e. epidemic and pandemic. Hence, the composition is of importance in safely treating mass infections of livestock and ensuring safe meat for human consumption or consumption of other animals as ingredient of feed.

BRIEF DESCRIPTION OF DRAWINGS:

-NIL-

DETAILED DESCRIPTION OF THE INVENTION

The composition is now disclosed in detail as below regarding its ingredients, dosage form, clinical evaluation, dosage and duration and side-effects if any.

Ingredients

Same are given in Table 6 below: Table 6: Ingredients of the composition

Dosage form formulation The dried, fine extracts in powder form are taken in appropriate quantities and blended to give a uniform blend. The same can be easily formulated into any suitable pharmaceutical dosage form for external and internal application e.g. tablets, capsules, syrup, lozenges etc. or oral use in the treatment of internal infections; injectable forms and also topical applications e.g. creams and ointments etc.

Example- 1 below details formulation of an oral dose form of the composition for the treatment of patients diagnosed with respiratory infections (Flu and bacterial infection). Example -1

Alcoholic extracts of the following were commercially purchased, in dried, fine powder form and blended as below:

Curcuma longa (95% Curcumim) -200 mg, Boswellia serrata (65% Boswellic acid)- 170 mg, Moringa pterygosperma ( leave ) -145 mg, Ocimum sanctum- 66mg, Tinospora cordifolia-66 mg, Withania somnifera ( leaves )-43 mg and Piper nigrum (95% Piperine) - 10 mg.

The fine blend was filled into capsules to give a single oral dosage form of 2 capsules of 700 mg each, thrice a day i.e. 4.2 g/day/adult for treatment of patients suffering from respiratory infections caused by viruses or bacteria.

The above example is purely illustrative. Obviously, variations in quantity of the ingredients and different pharmaceutical dosage forms and other forms e.g. solutions using the ingredients of the composition can be easily carried out by those skilled in the art. Such variations shall be within the scope of the invention.

Recommended dosage and duration for treatment of human subjects suffering from respiratory infections

Based on pharmacological and clinical inputs, a standard dose of 2 capsules of 700 mg each, thrice a day, i.e. 4.2 g/day/adult, after meals for minimum 7 days was felt to be appropriate. Same could be appropriately increased or decreased as per the clinical outcome and observations.

Clinical Evaluation Composition in single, oral dosage form i.e. 2 capsules of 700 mg each, thrice a day, i.e. 4.2 g/day/adult, after meals for minimum 7 days, was given to patients. Patients were clinically diagnosed as suffering from viral infection (flu) or mixed viral and bacterial infection. Details of Patients administered the composition is given in Table 7 below.

Table 7: Details of Patients and Clinical Diagnosis

Results

Details of clinical outcome are given in Table 8 below: Table 8: Clinical Outcomes of use of composition in Patients with Respiratory Infection

Treatment was continued for 7 days in all patients, to ensure complete elimination of any infection and prevent any relapse. In case of 6^th patient, therapy was continued for 10 days. Breathlessness persisted in case of 6^th patient and she was diagnosed as suffering from asthma. On treatment with standard modern (allopathic) medicines for asthma, patient got cured in due course of time.

Discussion - The dosage form when taken orally at prescribed dose for appropriate duration, was very effective in treating respiratory infections caused by viruses and bacteria. Further, unlike existing anti-viral drugs and antibiotics, it was totally free from any side-effects or undesirable effects. Owing to broad spectrum of activity against viruses and bacteria and also powerful immunoboosting properties, the composition provided quick relief.

In the present composition, no‘purified molecules’ or single‘compounds’ are present as in existing anti-viral drugs or antibiotics. Rather, the composition is a very unique cocktail of more than 50-70 phytochemicals present in the standardized extract of seven herbs. It is not possible for bacteria to develop resistance against this composition because resistance is developed against a single compound (antibiotic). When confronted with a complex mixture of molecules, bacteria fail to develop resistance and get killed. This is the reason why natural products documented in ancient texts hundreds of years old, still work i.e. bacteria have been unable to develop resistance against them over several hundreds of years! Secondly, several of the phytochemicals have very powerful anti-viral activity and totally annihilate a wide variety of viruses.

Present composition thus simultaneously performs the role of several ‘anti-viral drugs’, ‘antibiotics’ and ‘immunoboosters’ without any side effects. Use of standardized extracts eliminates batch to batch variation, ensures quality assurance of the product and approval by regulatory agencies and also easy clinical evaluation and correlation of results by clinicians and researchers across the world.

The herbs used in the formula are all well-documented in global scientific literature in terms of safety and efficacy, ensuring safety of the composition- for prophylactic use and also treatment.

Success of present invention - Scientific Rationale

New viruses produced as a result of mutation, cause existing drugs and vaccines to fail. Bacteria develop drug resistance and cause existing antibiotics to fail. Repeated annual outbreaks clearly show that existing medicines are ineffective to tackle the menace and there is a dire need for an innovative, low-cost approach. COVID-19 disease is a case in point, in which several patients have died worldwide and economic loss is beyond calculation.

The present invention has addressed these problems in a very innovative manner by not using any single purified molecule or chemical compound at all. Rather, it consists of standardized extracts of herbs with powerful three pronged activity- antibacterial, antiviral and immunoboosting. This is because the composition is practically a‘cocktail’ of more than a 50-70 phytochemicals derived from specific herbs combined in synergistic ratios. In absence of any single molecule or compound, neither viruses nor bacteria can develop‘resistance’ against the composition. Also, since the composition contains not one but several phytochemicals with powerful anti-viral, anti-bacterial activity, it acts simultaneously against several viruses and bacteria making treatment very easy.

Novelty, Inventive Step and Industrial Application Novelty

The antiviral, antibacterial, immuno-booster composition of present invention consisting of standardized commercially available alcoholic extracts of seven specific herbal ingredients combined together synergistically in specific ratios, is novel and not disclosed in prior art viz. Curcuma longa (95% Curcumin) 26-31%; Boswellia serrate resin (65% Boswellic acid)- 22- 27%; Moringa pterygosperma (leaves) - 18-23%; Ocimum sanctum (leaves) -7-12%; Tinospora cordifolia (stem) - 7-12%; Withania somnifera (leaves)- 5-7%; Piper nigrum fruit (95%

Piperine)- 1-2%.

Individual Anti-viral activity, antibacterial activity and also immunoboosting activity of several herbs has been disclosed in literature by several researchers from several countries across the world but a single synergistic compostion with three pronged action of anti-viral, anti-bacterial and immunoboosting properties, for treatment of internal and external infections caused by viruses and bacteria, as disclosed in present invention has not been disclosed anywhere in the prior art.

This clearly shows that the composition of present invention (consisting of standardized extracts of specific herbs, present in specific ratios) marks a significant advancement and breakthrough in the prophylaxis and treatment of external and internal viral and bacterial infections and such a composition is neither anticipated nor disclosed in the prior art. Inventive Step

The technical advancement of knowledge lies in disclosing a single composition of standardized commercially available alcoholic extracts, having very powerful and broad spectrum activity, simultaneously against several viruses and bacteria, enabling prevention and treatment of a wide variety of external and internal infections caused by bacteria and viruses, in humans as well as livestock. It eliminates the need for separate antivirals and antibiotics.

The invention also has economic value, as it drastically reduces the cost of treatment and also prevents losses caused due to sickness in humans or animals by preventing the same (Prophylactic use). Repeated annual outbreaks clearly show that existing medicines are ineffective to tackle the menace and there is a dire need for an innovative, low-cost approach as disclosed in present invention. COVID-19 disease is a case in point, in which several patients have died worldwide and economic loss is beyond calculation. Hence, the technical advancement of knowledge as disclosed in present invention marks a significant step forward in the easy and effective treatment of viral and bacterial infections, without side-effects and in a manner that ‘limitations’ of existing therapies based on synthetic drug or pure compound approach are overcome.

Industrial Application

The composition has widespread application in prevention and treatment of external and internal infections caused by bacteria and viruses.

It can be easily manufactured on a commercial scale by herbal product manufacturers and pharmaceutical companies engaged in the manufacture of dosage forms.

Claims

WE CLAIM:

1. An Anti-Viral Anti-Bacterial Immunoboosting Composition of Herbal Extracts

WHEREIN the same consists of standardized commercially available alcoholic extracts of seven specific herbs, combined together in specific synergistic ratios, as below:

i. Curcuma longa (95% Curcumim) - 26-31%

ii. Boswellia serrata (65% Boswellic acid)- 22-27%

iii. Moringa pterygosperma - 18-23%

iv. Ocimum sanctum -7-12%

v. Tinospora cordifolia- 7-12%

vi. Withania somnifera- 5-7%

vii. Piper nigrum (95% Piperine) - 1-2%.

2. An Anti-Viral Anti-Bacterial Immunoboosting Composition of Herbal Extracts

WHEREIN the same consists of standardized commercially available alcoholic extracts of seven specific herbs , combined together in specific synergistic ratios, as below:

i. Curcuma longa rhizomes (95% Curcumim) - 28.5 %

ii. Boswellia serrata resin (65% Boswellic acid) - 24.5 %

iii. Moringa pterygosperma (leaves) - 20.5 %

iv. Ocimum sanctum (leaves)- 9.5 %

v. Tinospora cordifolia (stem) - 9.5 %

vi. Withania somnifera (leaves) - 6 %

vii. Piper nigrum (95% Piperine) fruit - 1.5 %.

3. The Anti-Viral Anti-Bacterial Immunoboosting Composition of Herbal Extracts as Claimed in Claim 2 WHEREIN an oral dosage form of the same for the treatment of respiratory infections in humans consists of 700 mg of the extracts, combined together in single oral dosage form such as a capsule or tablet, in specific synergistic ratios, as below: i. Curcuma longa rhizomes (95% Curcumim) - 28.5 %

ii. Boswellia serrata resin (65% Boswellic acid) - 24.5 %

iii. Moringa pterygosperma (leaves) - 20.5 %

iv. Ocimum sanctum (leaves)- 9.5 % v. Tinospora cordifolia (stem) - 9.5 % vi. Withania somnifera (leaves) - 6 % vii. Piper nigrum (95% Piperine) fruit - 1.5 %.