WO2010086721A1

WO2010086721A1 - Herbal balm composition and methods of preparation thereof

Info

Publication number: WO2010086721A1
Application number: PCT/IB2010/000164
Authority: WO
Inventors: Ramesh Surianarayanan; Uddagiri Venkanna Babu; Rangesh Parmesh; Raviraj Udyavara Badya
Original assignee: Himalaya Global Holdings Limited
Priority date: 2009-01-30
Filing date: 2010-01-29
Publication date: 2010-08-05

Abstract

Disclosed herein is a herbal balm composition and the method of preparing said composition. The composition comprising extracts of organically certified herbs, organic essential oils and organic beeswax, wherein the extract is prepared employing a super critical fluid extraction (SCFE) and wherein the essential oils used herein is obtained by cold pressed method.

Description

HERBAL BALM COMPOSITION AND METHODS OF PREPARATION

THEREOF

Field of the Invention

This invention, in general relates to a herbal balm composition and methods of preparation thereof. In particular, the present invention provides herbal balm composition comprising organic essential oils, organic beeswax and other desired herbal components as medicated topical preparations for application to skin of human beings. Background of the Invention

Balms are topical preparations for application to skin to relieve pain and stiffness. These balms are typically formulated from alcohol, acetone or quickly evaporating solvents and counter irritant chemical compounds such as Methyl salicylate, Benzoin, Capsaicin or resin. Petroleum Jelly is the common base for any kind of balm.

Petroleum jelly or Petrolatum is the semi solid mixture of hydrocarbons and has become house hold preparation for various medical purposes. Petrolatum has associated with some of negative affects due to improper use including lipid pneumonia when inhaled from the nose. Petrolatum is not a material from renewable sources and not biodegradable which may be a cause of concern for environmental pollution etc.

Non organic essential oils are processed from herbal materials cultivated using pesticides and chemical fertilizers. Non-Organic essential oils are processed by chemical extraction and therefore all chances of presence of solvent residues and pesticides in normal oils.

In the recent years, the world is moving towards natural that are free from chemical substances which may be safe and save the planet from the pollution.

Organic farming is a step forward in this direction to grow herbal materials without using any pesticides and chemical fertilizers to produce crops that are safe and natural without any side affects.

It is therefore an important aspect for the personal care or cosmetic industries to develop cosmetic products that are being used daily by all age group of human beings are safe and composed of 100% natural ingredients. Prior Art

US Patent application no.20010005509 by Marie Harbeck discloses an improved and useful topical transdermal delivery composition for the alleviation and treatment of dermatitis, eczema, lupus, dry, cracked, flaking, peeling, and itching skin infirmities of the foot. The composition is in the form of a cream, comprising a mixture consisting of safflower oil, flaxseed oil, vitamin A, tocopherol linoleate and tincture of benzoin in addition to organic beeswax.

Patent application no. DE202005005557 (Ul) by Leibner Sieglinde reveals a herbal composition for treatment of rheumatism, gout, sciatica, joint pain and back pain. The herbal composition is formulated either in the form of oil or in the form of balm. The herbal composition contains St. John's wort extract, an arnica extract, essential oils, beeswax and sheabutter.

Patent application no. DEl 02005016138 (Al) by Leibner Sieglinde reveals about preparation of a natural remedy useful to cure bone rheumatism comprises a mixture of lavendulae ethers, eucalyptus ether and other essential oils in the form of herbal oil that is supplemented with sheabutter and beeswax in the form of herbal balm.

Summary of the Invention

It is a principal object of the present invention to provide a herbal balm composition comprising extracts of organically certified herbs, organic essential oils and organic beeswax, wherein the said composition is devoid of using any preservatives and chemical excipients. The further object is to provide a method of preparing herbal balm compositions comprising extracts of organically certified herbs, organic essential oils and organic beeswax, wherein said method is devoid of using any solvent.

Another object is to provide a herbal balm composition comprising extracts of organically certified herbs, organic essential oils and organic beeswax which are mixed to form a medicated topical application.

The above and the other objects of the present invention are attend according to following preferred embodiments of the present invention, however the scope of the invention is not restricted to the particular embodiment. In accordance with one embodiment of the present invention, there is provided a herbal balm composition comprising extracts of organically certified herbs, organic essential oils and organic beeswax, wherein the extract is prepared employing a super critical fluid extraction technique. In accordance with one preferred embodiment of the present invention, there is provided a herbal balm composition, wherein said composition comprising a herbal extract blend containing effective amount of the extracts of Melia azadirachta, Nelumbo nucifera, Glycyrrhiza glabra, in various combinations thereof.

In accordance with another embodiment of the present invention, there is provided a herbal balm composition comprising extracts of organically certified herbs, organic essential oil and organic beeswax, said extract of herbs is obtained from a blend of herbs and wherein the blend is used in the range of 0.001% to 5%.

Preferably the blend is used in the range of 0.001% to 1%.

In accordance with another embodiment of the present invention, there is provided a herbal balm composition comprising extracts of organically certified herbs, organic essential oil and organic beeswax, said organic essential oil is used in the range of 20% to 35%.

In accordance with still another embodiment of the present invention, there is provided a herbal balm composition comprising extracts of organically certified herbs, organic essential oil and organic beeswax, wherein the said composition is formulated in various kinds of balms.

In accordance with still another embodiment of the present, invention, there is provided a herbal balm composition comprising extracts of organically certified herbs, organic essential oil and organic beeswax, wherein the said composition is formulated into cold balm, massage balm, lip balm and foot balm.

In accordance with another embodiment of the present invention, there is provided a herbal balm composition comprising extracts of organically certified herbs, organic essential oil and organic beeswax, wherein the said composition is formulated into cold balm, Lotus flower lip care, massage/pain balm and foot care cream etc.

In accordance with another embodiment of the present invention, there is provided a cold balm composition comprising extracts of organically certified herbs, organic essential oil and organic beeswax, wherein said composition comprising a essential oil blend containing effective amount of oil of Mentha arvensis, Eucalyptus officinalis, Ocimum basillicum, Ocimum sanctum and Curcuma longa.

In accordance with another embodiment of the present invention, there is provided a lip care balm composition comprising extracts of organically certified herbs, organic essential oil and organic beeswax, wherein said composition comprising herbal blend extract of Melia azadirachta, Nelumbo nucifera and

Glycyrrhiza glabra.

In accordance with one embodiment, there is provided a method of preparation of various types of herbal balms wherein, the process comprises of blending organically certified herbs and extracting the resultant herbs, employing super critical fluid extraction method, mixing the resultant blend with organic beeswax and organic essential oils.

Detailed Description of the Invention While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples.

The present invention describes the preparation of balms which can be certified organic balms as per organic certification standards using organic essential oils and organic beeswax. The organic vegetable oil in the formula is of Indian origin like sesame and coconut. These balms comprise cold balm, pain balm, lip balm, body balm and foot balm etc.

The present invention further provides a process for preparation of various types of herbal balms wherein, the process comprises of blending the organically certified herbs and extracting the resultant herbs employing super critical fluid extraction method, mixing the resultant blend with organic beeswax and organic essential oils.

Essential oils are well known for their therapeutic properties in relieving pain and common cold. Organic essential oils are distilled or cold press from the organically grown herbal materials that are free from pesticides and very low heavy metals.

Beeswax is a natural wax produced in the bee hives of honey bees. It is a tough wax and formed from a mixture of several compounds. Its main components are palmitate, palmitoleate, hydroxypalmitate and oleate esters. It is natural and developed from renewable sources and biodegradable.

In accordance with another preferred embodiment of the present invention there is provided a herbal balm composition, wherein the said extract of herbs can be prepared by using any parts of herbs, preferably roots of Glycyrrhiza glabra, aerial parts of Ocimum sanctum, leaves of Melia azadirachta and flowers of Nelumbo nucifera.

In accordance with still another preferred embodiment of the present invention there is provided herbal balm composition, wherein said essential oils is selected from Mentha arvensis, Eucalyptus officinalis, Ocimum basillicum, Ocimum sanctum,

Curcuma longa, Foeniculum vulgare, Pogostemon cablin, Citrus limon, Rosmarinus officinalis and Mentha citrata in various combination thereof.

In accordance with one embodiment of the present invention, there is a process for extraction of essential oil from said herbs, wherein said extraction process employing cold pressed method.

The current invention is an outcome of many years of research at Himalaya to make Organic balms with organic beeswax, organic vegetable oils and organic essential oils to give the same benefits through renewable source, environmentally safe and free from contaminants like pesticide residue and heavy metals. The following non-limiting examples illustrate in details about the invention.

However, they are, not intended to be limiting the scope of present invention in any way.

Example- 1

Cold Balm : Balm Inhale -Exhale

Example-2

Method of Manufacturing

1. Weigh accurately Organic Beeswax and Organic Coconut oil into a stainless steel vessel fitted with a stirrer. Heat the vessel to 7O⁰C - 75⁰C. Mix gently. Ensure that the Organic Beeswax is completely molten & dispersed in the coconut oil medium. Filter through 100-mesh stainless steel sieve.

2. Cool the vessel to 55⁰C - 6O⁰C under stirring. Add Natural vitamin E and ARD 419 C (Phase B). Mix gently for 10-15 minutes. During mixing, maintain the temperature between 55⁰C & 6O⁰C. After 15 minutes, cool to 45⁰C under gentle stirring.

3. Fill the product into bottles between 40 & 45°c under stirring

4. Organic Mentha arvensis is cold pressed oil from leaves procured locally.

5. Organic Eucalyptus globulus is cold pressed oil from leaves procured locally.

6. Organic Ocimum basilicum is cold pressed oil from leaves procured locally.

7. Organic Ocimum sanctum is CO₂ extract prepared from aerial parts procured locally.

8. Organic Curcuma longa is CO₂ extract prepared from rhizomes procured locally.

Example-3

Lotus Flower Lip care:

Example-4

Method of Manufacturing

1. Weigh and blend Fennel Oil, Rosemary Oil and Patchouli Oil in a separate vessel.

2. Weigh and take Phase A in a Clean Jacketed melting kettle. Heat to 8O⁰C with stirring to melt the ingredients. Mix till homogenous.

3. Cool the contents of melting kettle to 65⁰C with mixing 4. Add Phase B, Phase C and mix well

5. Add Vitamin E and Phase E at 6O⁰C and mix well.

6. Filter the contents through stainless steel mesh # 100 to remove any foreign particles.

7. Fill the mixture into the stick containers when hot (55⁰C- 6O⁰C) 8. Allow it to cool in the containers and solidify without disturbing

Example-5

Preparation of extract from Organic Melia Azadirachta Leaf Extract by Super Critical Fluid Extraction

The dried material of leaves of Melia azadirachta were pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50⁰C at a high pressure of 280-320 bar using carbon dioxide as a super critical fluid for extraction for up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form.

Example-6 Preparation of extract from Organic Nelumbo nucifera flower by Super Critical Fluid Extraction

The dried material of flowers of Nelumbo nucifera was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50⁰C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form. Example-7

Preparation of extract from Organic glycyrrhiza glabra root by Super Critical Fluid Extraction

The dried material of Glycyrrhiza glabra root was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50⁰C at high pressure of 280-320 bar using carbon dioxide as super critical fluid for extraction up to 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form Example-8

U-Knead-It (massage balm)

Example-9

Manufacturing Procedure

1. Weigh accurately Organic Beeswax and Organic Coconut oil into a stainless steel vessel fitted with a stirrer. Heat the vessel to 7O⁰C- 75⁰C. Mix gently. Ensure that the Organic Beeswax is completely molten & dispersed in coconut oil medium. Filter through 100-mesh stainless steel sieve.

2. Cool the vessel to 55⁰C - 6O⁰C under stirring. Add Natural vitamin E and Phase C. Mix gently for 10-15 minutes. During mixing, maintain the temperature between 55⁰C & 6O⁰C. After 15 minutes, cool to 45⁰C under gentle stirring.

3. Fill the product into bottles between 40 & 45⁰C under stirring.

4. Organic Mentha arvensis is cold pressed oil from leaves procured locally.

6. Organic Citrus Limon is cold pressed oil from peel procured locally. 7. Organic Rosmarinus officinalis is cold pressed oil from aerial parts procured locally.

Example- 10 Intensive Moisturizing FootCare Cream:

Example- 11

Manufacturing procedure: 1. Blend Dill oil, Mentha Citrata & essential oils in a SS vessel and keep aside.

2. In a separate vessel disperse Xanthan Gum & Carrageenan in the Glycerine. Ensure that no lump formation takes place.

3. Take water in the main vessel. Add Phase A & mix well till uniform. Add Coco- glucoside. Mix it well & start heating. Heat to 80⁰C. 4. Weigh & take Phase C in the melting kettle. Heat to 80⁰C.

5. Transfer oil phase to aqueous phase at 8O⁰C. Mix under homogenizer for 15-20 minutes.

6. Start cooling.

7. Dissolve Potassium Sorbate in Water & add to the main vessel at 5O⁰C & mix well.

8. Add Soliga honey & natural vitamin E at 45⁰C & mix well.

9. Add the perfume blend Phase G and mix well for 15-20 min

Example -12

A clinical study to evaluate the safety and efficacy of Comforting Cold Balm in individuals with

Common cold

Common cold is the most common reason for nose getting blocked with mucus. Common cold arises from exposure to environmental factors, such as wind, cold, heat, dampness, or dryness. These pathogens invade our body when our immunity is low. Common cold, also known as acute coryza, is an inflammation of upper respiratory tract. It is caused by infection with virus. Upper respiratory tract infections are the most common infectious diseases among adults and teens, who have two to four respiratory infections annually. Adults on an average have 2 to 3 colds per year and children 6 to 10, depending on their age and exposure. Children's noses are the major source of cold viruses. The first sign of cold is a feeling of soreness in the throat and congestion (stuffiness) of the nasal passage. Although the disease normally begins in the nose and throat, it affects all parts of the body. The usual symptoms of common cold are nasal stuffiness, sneezing, a rise in temperature, headache, sore throat and cough, aches and pains in the body, and loss of appetite. The skin around the nostrils may become sore. Many people with a cold feel tired and achy. These symptoms typically last for 3-10 days.

This study was an open, non-comparative, non-randomized, clinical trial. Hundred patients from both sexes, belonging to the age group of 18-60 years, and clinically diagnosed with Common cold were included in the study. Comforting Cold Balm was given to all the subjects and instructed to apply it daily. They were advised to visit at the end of every 2nd week .The patients were assessed on the basis of reduction in oiliness, moisturizing effect, soothing effect and cleansing effect.

The overall clinical assessment was defined as cured, improved and unchanged. The grading was done as follows: Severe: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0. The clinical indications such as Headache, Cold, Rhinitis, Congestion and blocked nasal passages. The study was conducted for 2 weeks. Directions for use:

To be applied locally on the nose, forehead, and chest or as may be directed by the physician. Study Design:

This pilot study was an open, non-comparative, non-randomized, clinical trial.

Primary and Secondary End points:

The predefined primary efficacy endpoints were rapid clinical improvement in Common cold. The predefined secondary endpoints for short- and long-term safety were assessed by incidence of adverse events and patient compliance to the therapy. Inclusion Criteria: Hundred patients of both sexes, belonging to the age group of 18-60 years, and presenting with Common cold and Subjects who were willing to give a written informed consent and follow the schedule and who had not participated in a similar investigation in the past four weeks were enrolled in the study. Exclusion Criteria:

Children below eighteen years of age, pre-existing systemic disease necessitating long-term medications, genetic and endocrinal disorders, subjects with known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or its components or ingredients in the test products and those who refused to give informed consent, were excluded from the study. Pregnant and lactating women were also excluded from the study.

Study Procedure:

Before entering into the study, the subjects were pre-screened by the investigator for the criteria indicated in the Subject Selection section. Only subjects who met the requirements of this section, who were willing to sign an informed consent form and have an updated medical history on file with the investigator, were enrolled for the study.

A written consent was obtained from each of the volunteers after confirming their total fitness to participate in the study. Comforting Cold Balm was given to all the subjects and instructed to apply it twice weekly over the nose and fore head. They were required to visit for follow-up at the end of every week for 2 weeks.

No other topical or systematic antibiotics were permitted during the trial. Patients were told to restrict themselves to "Comforting Gold Balm" as the only treatment for Common cold, and resort to no other active treatment intervention during the study period. Criteria for evaluation:

The response to therapy was evaluated at weekly intervals for 2 weeks by calculating the reduction in the symptoms of cold and the efficacy determined by the percentage reduction in the condition at the end of two weeks of treatment. The scoring was in turn correlated with response to the treatment as follows: Also response to therapy was evaluated on following symptoms of common cold like Rhinorrhea, sneeze, headache, fever, nasal congestion, cough and itching in the throat Response was evaluated on the visual analogue scale of 0-3. 0-nil: l-mild,

2- moderate: 3- severe. The scoring was in turn co related with response to the treatment as follows.

1. Poor response < 25% reduction

2. Fair response 25-49%

3. Good response 50-74%

4. Excellent response >75% FOLLOW-UP AND ASSESSMENT:

All the adverse events, either reported or observed by the patients, were recorded with information about severity, date of onset, duration, and action taken regarding the study drug. Relation of adverse events to study medication was predefined as "Unrelated" (a reaction that does not follow a reasonable temporal sequence from the administration of the drug), "Possible" (follows a known response pattern to the suspected drug, but could have been produced by the patient's clinical state or other modes of therapy administered to the patient), and "Probable" (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient's clinical state). Patients were allowed to voluntarily withdraw from the study, if they experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. For patients withdrawing from the study, efforts were made to ascertain the reason for dropout. Statistical Analysis: Statistical analysis was undertaken according to intention-to-treat principles.

The changes in various parameters from baseline values and the values after 2 weeks were evaluated by "Paired '/' Test". The minimum level of significance was fixed at 99% confidence limit and a 2-sided p value of <0.0001 was considered significant. Results: Ninety-four out of hundred subjects who had participated in the trial completed the 2 week follow-up. Six patients could not complete the scheduled follow-up due to their personal problems in visiting the skin unit within the stipulated time. Demographic data including age, gender, and history of smoking, alcohol consumption, and diet were tabulated in Table- 1

Table- 1

The results of the study were analysed statistically by students 't' test. Statistically significant (p<0.05) improvement in the symptoms were seen all the symptoms of common cold like Rhinorrhea, sneeze, headache, fever, nasal congestion, cough and itching in the throat and tabulated in Table.2

Table- 2

Thus, significant symptomatic relief observed after 2 weeks of treatment with Comforting Cold Balm in this clinical trial indicates that Comforting Cold Balm is effective agent in patients with common cold. Adverse effects:

There were no patients with a poor response by the end of the study period and none of the patients reported any adverse effects during the entire period of the trial. All volunteers displayed an adequate acceptance to the trial medication. No worsening of wound was observed in any patient during the trial. None of the patients complained of any side effects or untoward reactions are mentioned in Table.3.

Table-3

Example- 13

Clinical and Safety evaluation of Organique Soothing massage balm Aim of the study:

This pilot study was planned to evaluate the clinical efficacy of Soothing massage balm in Myalgia. The pilot study was conducted for 2 weeks. Study design:

This pilot study was an open, non-comparative, non-randomized, clinical trial. Primary and secondary endpoints:

The predefined primary efficacy endpoints were rapid clinical improvement in Myalgia. The predefined secondary endpoints for short- and long-term safety were assessed by incidence of adverse events and patient compliance to the therapy. Inclusion Criteria:

Hundred patients of both sexes, from the age group of 18-60 years, and presenting with Myalgia and Subjects who were willing to give a written informed consent and follow the schedule and who had not participated in a similar investigation in past four weeks were enrolled in the study

Exclusion criteria:

Study Procedure:

Before entering into the study, the subjects were pre-screened by the investigator for the criteria indicated in the Subject Selection section. Only subjects who meet the requirements of this section, who are willing to sign an informed consent form and have an updated medical history on file with the investigator, were enrolled into the study.

A written consent was obtained from each of the volunteers after confirming their total fitness to participate in the study. Soothing massage balm will be given to all the subjects and instructed to apply it twice daily over the affected part. They were required to visit for follow-up at the end of every week for a period of 2 weeks. The overall clinical assessments were defined as cured, improved and unchanged. The grading was as follows: Severe: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0. No other topical or systematic antibiotics were permitted during the trial. Patients were told to restrict themselves to "Soothing massage balm" as the only treatment for Myalgia, and resort to no other active treatment intervention during the study period. Criteria for evaluation: The response to therapy was evaluated at intervals of weekly intervals for 2 weeks by calculating the reduction in symptoms and the efficacy determined by the percentage reduction in the condition at the end of two weeks of treatment. Also response to therapy will be evaluated on following points, Reduction in pain intensity, reduction in swelling, reduction in tenderness, soothing effect. Response will be evaluated on the visual analogue scale of 0-3. 0-nil, 1- mild, 2- moderate, 3-severe. The scoring will be in turn co-related with response to the treatment as follows.

1. Poor response < 25% reduction

2. Moderate response 25-49% 3. Good response 50-74%

4. Excellent response >75% FOLLOW-UP AND ASSESSMENT:

Subjects will be assessed on entry and at the end of every week for 2 Weeks. The patients were assessed on the Reduction in pain intensity, reduction in swelling, reduction in tenderness and soothing effect. Clinical assessment was defined as cured, improved and unchanged. The grading was done as follows: Good: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0

At every check-up the clinical response to the condition, any adverse events, and patient compliance was assessed. All the adverse events, either reported or observed by the patients, were recorded with information about severity, date of onset, duration, and action taken regarding the study drug. Relation of adverse events to study medication was predefined as "Unrelated" (a reaction that does not follow a reasonable temporal sequence from the administration of the drug), "Possible" (follows a known response pattern to the suspected drug, but could have been produced by the patient's clinical state or other modes of therapy administered to the patient), and "Probable" (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient's clinical state).

Patients were allowed to voluntarily withdraw from the study, in case they experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. For patients withdrawing from the study, efforts were made to ascertain the reason for dropout. Statistical analysis:

Statistical analysis was done according to intention-to-treat principles. The changes in various parameters from baseline values and the values after 2 weeks were evaluated by "Paired 't' Test". The minimum level of significance was fixed at 99% confidence limit and a 2-sided/? value of <0.0001 was considered significant. Results:

Ninety-four out of hundred subjects who had participated in the trial completed the 2 weeks of follow-up. Six patients could not complete the scheduled follow-up due to their personal problems in visiting the skin unit within the stipulated time.

Demographic data including age, gender, and history of smoking, alcohol consumption, and diet were tabulated. Also history of previous injuries or trauma and previous medication was recorded in Table- 4.

Table-4

At the end of 1st week there were 3% patients with poor response, 18 % with fair response, 34 % with good response and 45 % with excellent response, which improved to 17% patients with fair response, 34 % with good response and 49 % with excellent response at the end of 2 weeks mentioned in Table 5.

Table-5

Thus, significant symptomatic relief was observed after 2 weeks of treatment with Soothing Massage Balm in this clinical trial indicate that Soothing Massage Balm is effective agent in patients with Myalgia. Adverse effects:

There were no patients with a poor response by the end of the study period and none of the patients reported any adverse effects during the entire period of the trial. All volunteers displayed an adequate acceptance to the trial medications. None of the patients complained of any side effects or untoward reactions given in Table.6

Table-6

Hyperpigmentation 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00

Values are expressed in mean ± SD.

Example- 14

An open label prospective clinical study to evaluate the efficacy and safety of Intensive Moisturizing Foot Care Cream in management of cracked heels, Study procedure:

All enrolled patients underwent a through clinical examination, with special emphasis on local skin examination. All patients were advised to apply sufficient quantity of "Intensive Moisturizing FootCare cream", to the cracked heels, for a period of 6 weeks with gentle massage. Patients were told to restrict themselves to the Intensive Moisturizing FootCare cream as the only treatment for their cracked heels and resort to no other active treatment intervention during the study period was allowed.

Criteria for evaluation:

The response to therapy was evaluated at intervals of two weeks up to the 6^th week. The criteria for evaluation were signs and symptoms like Cracks, Dryness of soles, Pain, Bleeding of soles.

Assessment was done on the basis of following grading scale: Cracks: - 0. No cracks

1. Dry soles with 1 -2 cracks. 2. 5-7 cracks

3. Many superficial cracks with slight pain

4. Slight deep cracks with moderate pain.

5. Deep cracks with severe pain, which causes difficulty in walking. Dryness of sole: 0. No dryness.

1. Slight dry

2. Dryness only at the cracks

3. Dryness over the entire sole. Pain: 0. No pain

1. Slight pain in cracks only while walking barefooted

2. Pain while walking, but manageable

3. Unbearable pain. Bleeding of soles:

0. No bleeding.

1. Slight bleeding from deep cracks.

2. Moderate bleeding from deep cracks.

3. Bleeding from all the cracks with severe pain. FOLLOW-UP AND ASSESSMENT

All patients were reviewed for a period of 6 weeks at 2-week intervals and at each follow-up visit, they were asked about the frequency of application and overall compliance to the treatment. Clinical assessment of was done objectively (by the investigator) and also subjectively (by patient). Thorough examination was done after completion of 2 weeks and at the end of the study.

At every check-up the clinical response to the acne treatment, any adverse events, and patient compliance was assessed.

All the patients were questioned for any untoward effects of the medications for erythema, edema, pain, pruritus and urticaria, burning sensation, hypopigmentation or hyperpigmentation. These untoward effects were rated on a scale ranging from 0 (none) to 3 (severe).

All adverse events, either reported or observed by the patients, were recorded with information about severity, date of onset, duration, and action taken regarding the study drug. Relation of adverse events to study medication was predefined as "Unrelated" (a reaction that does not follow a reasonable temporal sequence from the administration of the drug), "Possible" (follows a known response pattern to the suspected drug, but could have been produced by the patient's clinical state or other modes of therapy administered to the patient), and "Probable" (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient's clinical state). Patients were allowed to voluntarily withdraw from the study, in case they experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. For patients withdrawing from the study, efforts were made to ascertain the reason for dropout. Statistical analysis:

Statistical analysis was done according to the intention-to-treat principles. The changes in various parameters from baseline values and the values after 6 weeks were evaluated by "Paired 7' Test". The minimum level of significance was fixed at 95% confidence limit and a 2-sided p value of <0.05 was considered significant. Results:

Ninety-seven out of hundred patients included in the trial completed the eight weeks of follow-up. Three patients could not complete the scheduled follow-up due to their personal problems in visiting the skin unit within the stipulated time. Demographic data including age, gender, history of smoking, alcohol consumption, and diet were tabulated. Also history of previous medication was recorded in Table 7.

Table-7

All patients responded well to the treatment. Statistically Significant reduction in number of cracks was seen at the end of the study. Also there was significant reduction in other symptoms such as dryness of sole, pain and bleeding of soles mentioned in Table- 8. Table-8

Thus, significant symptomatic relief was observed after 6 weeks of treatment 5 with Intensive Moisturizing FootCare cream. The results in this clinical trial indicate that Intensive Moisturizing FootCare cream is effective agent in patients with cracked heels. Adverse Effects:

There were no patients with a poor response by the end of the study period and

10 none of the patients reported any adverse effects during the entire period of the trial.

All volunteers displayed an adequate acceptance to the trial medications. No worsening of symptoms was observed in any patient during the trial. None of the patients complained of any side effects or untoward reactions given in Table. 9

Table-9

Example- 15

A clinical study to evaluate the efficacy and safety of Lip Care - Soothing Lotus Flower in dry, chapped and cracked lips Cracked, dry or sore lips are both unsightly and painful. They can be caused by a variety of conditions, and can also be symptoms of more serious illnesses. Lips are skin, similar in many respects to the skin on the rest of your body, but unlike skin the lips do not produce natural oils to protect them. The commonly seen clinical presentation is peeling of the lips (flaky skin), Cracks or bleeding from the sides of the mouth, Sensitive lips that appear otherwise healthy, Painful lips, Open sores, marks or similar symptoms.

Causes of cracked and dry lips include: Extremities in weather, Sun damage, Wind exposure, Dehydration. Probably the leading cause of most dry or cracked lips is simple dehydration. If the body does not have enough water, the extremities including the lips, will show that lack first. Smoking or chewing tobacco, Vitamin deficiencies. Certain vitamins are critical to maintaining healthy skin and lips. These include: Vitamin A, Vitamin B, Vitamin C, Vitamin B2 (Riboflavin deficiency), and Allergic reactions. Many cracked and dry lips are the result of negative reactions to cosmetics and skin care products, ill-fitting dentures. More serious conditions are considered in Kawasaki Disease, Sjogren's Syndrome, Macrocytosis. This study was an open, non-comparative, non-randomized, clinical trial. Hundred patients of both sexes, from the age group of 18-60 years, and clinically diagnosed with dry, chapped and cracked lips were included in the study. Lip Care - Soothing Lotus Flower was given to all the subjects and instructed to apply it twice daily all over the lips generously. They were advised to visit at the end of 1^st week and at the end of 2^nd week or till the lesions healed. The patients were assessed on the number of cracks that had healed, intensity of pain and if any discharge from the cracks.

The overall clinical assessment was defined as cured, improved and unchanged. The grading was done as follows: Severe: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0 and also for any reactions of erythema, irritation swelling. Aim of the study:

This pilot study was planned to evaluate the clinical efficacy of Lip Care - Soothing Lotus Flower in the management of dry, Chapped and cracked lips and study was conducted for two weeks. Primary and Secondary End Points:

The predefined primary efficacy endpoints were rapid clinical improvement in dry, Chapped and cracked lips. The predefined secondary endpoints for short- and long-term safety were assessed by incidence of adverse events and patient compliance to the therapy. Inclusion Criteria:

Hundred patients of both sexes, from the age group of 18-60 years, and presenting with dry, chapped and cracked lips and Subjects who were willing to give written informed consent and follow the schedule and who had not participated in a similar investigation in past four weeks were enrolled in the study. Exclusion Criteria:

Children below eighteen years of age, patients with severe infected wounds, preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders, subjects with known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or its components or ingredients in the test products and those who refused to give informed consent, were excluded from the study. Pregnant, and lactating women were also excluded from the study. Study Procedure:

A written consent was obtained from each of the volunteers after confirming their total fitness to participate in the study. Lip Care - Soothing Lotus Flower was given to all the subjects and were instructed to apply it twice daily over the affected area of the lips. They were required to visit for follow-up at the end of every 2 weeks interval up to 6 weeks or until healed. The overall clinical assessments were defined as cured, improved and unchanged. The grading was done as follows: Severe: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0.

No other topical or systematic antibiotics were permitted during the trial. Patients were told to restrict themselves to "Lip Care - Soothing Lotus Flower" as the only treatment for treating dry, chapped and cracked lips, and resort to no other active treatment intervention during the study period. Criteria for evaluation:

The response to therapy was evaluated at intervals of 2 weeks for a period of 6 weeks by calculating the reduction in the lip condition of dry, chapped and cracked lips and the efficacy determined by the percentage reduction in the lip condition at the end of two weeks of treatment. Improvement in the form of reduction in the Lip condition was graded as shown in Table 10.

Table- 10

The scoring was in turn correlated with response to the treatment as follows:

0 - No improvement

1 - Poor response

2 - Fair response 3 - Good response

4 - Excellent response

This dual response assessment provided better treatment evaluation of the therapy.

FOLLOW UP AND ASSESSMENT Subjects assessed on entry, at the end of 2nd week, 4^th week and at the end of 6^th

Week.

The patients were assessed on the number of cracks in the lips that had healed, intensity of pain in the lips and oral mucosa and any discharge from the lips, Reduction in dryness of lips, Reduction in chapped, cracked lips, Soothing and smoothing effect, Softening effect. The overall clinical assessment was defined as cured, improved and unchanged. The grading was done as follows: Severe: 3, Moderate: 2, Mild: 1, Disappearance of the symptoms: 0

At every check-up, the clinical response to the lip condition, any adverse events, and patient compliance was assessed. All the adverse events, either reported or observed by the patients, were recorded with information about severity, date of onset, duration, and action taken regarding the study drug. Relation of adverse events to study medication was predefined as "Unrelated" (a reaction that does not follow a reasonable temporal sequence from the administration of the drug), "Possible" (follows a known response pattern to the suspected drug, but could have been produced by the patient's clinical state or other modes of therapy administered to the patient), and "Probable" (follows a known response pattern to the suspected drug that could not be reasonably explained by the known characteristics of the patient's clinical state).

Patients were allowed to voluntarily withdraw from the study, if they had experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. For patients withdrawing from the study, efforts were made to ascertain the reason for dropout. Statistical Analysis:

Statistical analysis was conducted according to intention-to-treat principles. The changes in various parameters from baseline values and the values after 6 weeks were evaluated by "Paired ^lf Test". The minimum level of significance was fixed at 99% confidence limit and a 2-sided/? value of O.0001 was considered significant. Results:

Ninety-four out of hundred subjects who had participated in the trial completed the 6 weeks of follow-up. Six patients could not complete the scheduled follow-up due to their personal problems in visiting the skin unit within the stipulated time.

Demographic data including age, gender, history of smoking, alcohol consumption, and diet were tabulated. Also history of previous injuries or trauma and previous medication was recorded in Table 11.

Table- 11

At the end of 2^nd week there were 3% patients with poor response, 20 % with fair response, 54 % with good response and 23 % with excellent response, which improved to 7% patients with fair response, 44 % with good response and 49 % with excellent response at the end of 4 weeks and at the end of 6 weeks 30% showed good response and 70% showed excellent response to Lip Care - Soothing Lotus Flower given in Table 12 Table- 12

Thus, significant symptomatic relief was observed after 2 weeks of application of Lip Care - Soothing Lotus Flower and continued till the end of the study. The results in this clinical trial indicate that Lip Care - Soothing Lotus Flower is effective agent in individuals with Dry, chapped and cracked lips. Adverse Effects:

There were no patients with a poor response by the end of the study period and none of the patients reported any adverse effects during the entire period of the trial. All volunteers displayed an adequate acceptance to the trial medications. No worsening of wound was observed in any patient during the trial. None of the patients complained of any side effects or untoward reactions mentioned in Table 13.

Table- 13

Dermal Safety Evaluation Of Lip Care - Soothing Lotus Flower (n=100)

Days of application

Signs & Symptoms Initial End of End of End of 2 weeks 4 weeks 6 weeks

Erythema of the lips 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00

Edema and swelling of the

0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 lips

Pain over the lips and

0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 mucosa surrounding lips

Pruritus and Urticaria 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00

Conclusion:

The above observations show that the Comforting Cold Balm has a positive role in treating patients with Common cold effectively, without any side effects and contraindications. The significant symptomatic relief was observed after 2 weeks of treatment with Soothing massage balm and is effective agent in patients with Myalgia, without any side effects and contraindications. The above observations indicate good clinical efficacy of Intensive Moisturizing FootCare cream in the management of cracked heels. The above observations show that Lip Care - Soothing Lotus Flower has a positive role in treating patients with dry, chapped and cracked lips effectively, without any side effects and contraindications.

While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those precise embodiments. Rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations would present themselves to those skilled in the art without departing from the scope and spirit of this invention.

Claims

We Claim

I . A herbal balm composition comprising extracts of organically certified herbs, organic essential oils and organic beeswax, wherein the extract is prepared employing a super critical fluid extraction.

2. The composition according to claim 1, wherein the extract of herbs is obtained from a blend of herbs selected from Melia azadirachta, Nelumbo nucifera, Glycyrrhiza glabra or a combination thereof.

3. The composition according to claim 1, wherein the essential oil is selected from Mentha arvensis, Eucalyptus officinalis, Ocimum basillicum, Ocimum sanctum, Curcuma longa, Foeniculum vulgare, Pogostemon cablin, Citrus limon, Rosmarinus officinalis, Mentha citrata or a combination thereof.

4. The composition according to claim 1, wherein the organic essential oils is obtained by cold press method.

5. The composition according to claim 2, wherein the blend is used in the range of 0.001% to 5%.

6. The composition according to claim 5, wherein the blend is used in the range of 0.001% to 1%.

7. The composition according to claim 1, wherein the beeswax is used in the range of20% to 35%.

8. The composition according to claim 3, wherein the organic essential oils is used in the range of 20% to 35%.

9. The composition according to claim 1, wherein the composition is formulated in various types of balms.

10. The composition according to claim 9, wherein the balm is cold balm/ lip balm/ massage balm/ foot care cream.

I 1. The composition according to claim 10, wherein the lip care balm comprising extracts of the blend of herbs Melia azadirachta, Nelumbo nucifera, Glycyrrhiza glabra, essential oils and organic beeswax.

12. The composition according to claim 1, wherein said composition is prepared by the process comprising blending of organically certified herbs and extracting the resultant herbs employing super critical fluid extraction (SCFE), mixing the resultant extract of blend with organic beeswax and organic essential oils.