WO2015185158A1

WO2015185158A1 - A composition and device for treatment of diabetes

Info

Publication number: WO2015185158A1
Application number: PCT/EP2014/061861
Authority: WO
Inventors: Awad MANSOUR
Original assignee: AYDIN, Ahmet Nurettin
Priority date: 2014-06-06
Filing date: 2014-06-06
Publication date: 2015-12-10

Abstract

The present invention relates to a topical pharmaceutical composition for treatment of diabetes mellitus. The composition for treating diabetes, preferably formed of gel or cream, contains vitamin B3, Galega officinalis, Berberis Vulgaris or extracts of these. The present invention further proposes a device which is capable of applying at least one of a micro-current or ultrasound to human skin onto which the topical pharmaceutical composition is applied. Said device transmits acoustical energy from an ultrasonic generator, through the skin of a patient where the composition is applied, for the purpose of increasing the release of biofunctional compounds from a targeted organ. In particular the composition and device are used together on acupuncture and reflexological points of a human body to cause the release of insulin from the patient's pancreas to enhance the treatment of diabetes.

Description

A COMPOSITION AND DEVICE FOR TREATMENT OF DIABETES

Technical Field of the Invention

The present invention relates to a composition and device for treating diabetes mellitus. More particularly, the present invention relates to a composition, formed as a cream or a gel, which is used with a therapy device capable of applying at least one of a micro-current or ultrasound onto acupuncture and reflexological points of a human body for treating diabetes. Background of the Invention

Diabetes mellitus, shortly referred to as diabetes, is a chronic condition in which a person has elevated blood glucose levels that result from defects in the body's ability to produce and/or use insulin. There are two main types of diabetes. One of them is type 1 diabetes usually strikes children and young adults, and may be genetic, and/or environmental. The other one is Type 2 diabetes accounts for 90-95% of diabetes cases and is linked to obesity and physical inactivity.

Diabetes is a serious health problem that can lead the patient to several physiological complications. According to World Health Organization, at least 171 million people have a medical condition of diabetes, or 2.8% of the whole world population. Diabetes occurrence is increasing quickly, and it is estimated that by 2030, this number will be approximately 366 million people.

Diabetes is generally time-consuming for patients because of the need to consistently obtain reliable diagnostic information, follow prescribed therapy, and manage lifestyle on a daily basis. Diagnostic information is typically obtained from a blood sample with a device and is then measured with a handheld blood glucose meter. Interstitial glucose levels may be obtained from a continuous glucose sensor worn on the body. Patients with diabetes and their healthcare professionals interact with a variety of medical devices and systems to help manage the disease. Currently, the clinical mostly use for the treatment of diabetes drugs to control blood sugar level, medications to control diabetes. Drug therapy is used to replace the function of the pancreas. This can be very time-consuming for patients. There are more than dozens kinds of therapy methods for treating diabetes such as electro-acupuncture and reflexological therapy. Scientific studies and clinical tests have shown that acupuncture can help diabetic patients. The treatment for diabetes focuses on regulating the circulation of blood and energy and balancing the organ systems to improve pancreatic function and address internal heat and the depletion of fluids. Electro-Acupuncture therapy originated in China more than 2000 years ago and is an important component of Traditional Chinese Medicine (TCM). As per the TCM, health is maintained by keeping the human body in a 'balanced state'. Acupuncture consists of stimulating some special points on the body using fine needles, so as to restore the balance of body. With its growing worldwide popularity, acupuncture is now considered as one of the important complementary and alternative medicine (CAM) therapies worldwide.

Another therapy method for treating diabetes is reflexological therapy. It is also one of the most popular natural methods that many doctors prescribe as complementary treatment to various ailments, including a chronic lifelong disease like diabetes, is reflexology, and the numbers of studies that prove and laud its use continue to increase. Data from the Reflexology Association of Connecticut (RACT) titled Reflexology Footnotes: Diabetes and Reflexology, which came out in January 2007, revealed that reflexology stimulates the pancreas and liver, thereby aiding in the maintenance of healthy blood sugar levels. It further showed that reflexology is a holistic treatment that can effectively heal vulnerable organs, reduce blood sugar level fluctuations, as well as help alleviate stress and tension, which cause many health problems including diabetes.

Moreover, using compositions including hypoglycemic extracts are known for treatment of diabetes. Such as Berberis Vulgaris and Galega are known to be hypoglycemic antidiabetic ingredients and their extracts are used orally to treat diabetes but not as one formula containing all of them together formed as a cream or a gel. A prior art reference, among many others, relevant to the technical field of the present invention is the W02009/001362 publication. It relates to the field of therapeutic natural products, particularly to plant extracts effective in treating and preventing diabetes and/or conditions associated therewith. However, the herbal composition is used as an oral formulation not as a topical (external) formula on abdominal pancreatic area, eyes, ears, penis, umbilicus, hands and feet. Another prior art reference, among others, relevant to the technical field of the present invention is the CN2757857 publication. It discloses a spherical therapeutic electrode for diabetes. The device is composed of a spherical body and a smooth or a convex surface, wherein the spherical body is provided with an electrode jack and is made of nontoxic electro-conductive rubber or metallic materials. The spherical electrode can directly come in contact with acupuncture points on the palms of a human body, and electrical impulses are used for stimulating the acupuncture points, so as to promote blood circulation. However, in this document the electrodes are used only on the palms of a human body. In addition a document is silent about a usage of composition for the treatment of diabetes.

Objects of the Invention The present invention provides a composition comprising hypoglycemic ingredients, which is defined by the characterizing features as defined in Claim 1.

Primary object of the present invention is to provide a composition for repairing pancreatic function of humans and for reducing blood sugar in order to treat diabetes.

Another object of the present invention is to provide a device which is used with the composition that triggers acupuncture points non-invasively without using needles.

Another object of the present invention is to provide a device capable of using a micro- current combined with HVPC therapy and acoustic waves for treatment of diabetes.

Another object of the present invention is to provide a process for the preparation of the herbal composition for treating diabetes; said process comprises herbal mix or pharmaceutically acceptable additives/carriers.

Another object of the present invention is to provide a device for enhancing or increasing the release of insulin in a diabetic patient by use of acoustic waves, wherein the device is self-powered or portable. Summary of the Invention

The present invention relates to a topical pharmaceutical composition for treatment of diabetes mellitus. The composition for treating diabetes, preferably formed of gel or cream, contains vitamin B3, Galega offici alis, Berberis Vulgaris or extracts of these. The present invention further proposes a device which is capable of applying at least one of a micro-current or ultrasound to human skin onto which the topical pharmaceutical composition is applied. Said device transmits acoustical energy from an ultrasonic generator, through the skin of a patient where the composition is applied, for the purpose of increasing the release of biofunctional compounds from a targeted organ. In particular the composition and device are used together on acupuncture and reflexological points of a human body to cause the release of insulin from the patient's pancreas to enhance the treatment of diabetes. Detailed Description of the Invention

Present invention relates to the use of a composition which can be formed as a cream or a gel that capable of improves metabolism which leads to blood sugar reduction. Said composition is used with a device as a therapy method for increase the absorption of the composition and trigger acupuncture points non-invasively; i.e. without using needles in the human body. According to a first aspect of this invention, a composition is provided for treating diabetes, which comprises as an herbal mix thereof, in combination with a pharmaceutically acceptable solid or liquid carrier. Active ingredients of the said composition go directly to the targeted zone deep within the cell where they can perform to their maximum potential.

In one aspect, the pharmaceutical composition comprises:

Composition Percentage % Function

Ethoxylated Fatty Alcohols 5-10 Emulsifiers

Liquid Paraffin 10-15 Emollient

Aloe Vera Gel 5-15 Moisturizer

Chamomile Extract 5-10 Softener

Calendula Extract 3-8 Softener

Perfume 0.1 - 1

Euxyl K100 0.1 - 1 Preservatives

Herbal Mix (Niacinamide, Galega 0,1-30 Hypoglycemic offici alis and Berberis vulgaris)

Water Complementary

amount

Each extracts of Vitamin B3 (Niacinamide), Berberis Vulgaris and Galega officinalis ,as a herbal mix, are added to a base cream with 0.1 -10 % by weight to form a cream or a gel which is ,then, used topically at the acupuncture and/or refloxoligical points on: hands, feet, pancreas area, umbilicus, ears together with the stimulation device. The topical pharmaceutical composition is preferably formed as a cream or a gel. In the composition for treating diabetes according to the first aspect of this invention, Niacinamide may preferably be in the form of Vitamin B3. Amount of the each extracts of the herbal mix (Niacinamide, Berberis Vulgaris and Galega officinalis) is from 0.50 to 10 % by weight of the total composition; preferably each of them is 3.0 to 7.0 %. Ethoxylated Fatty Alcohols is used as an emulsifier for the composition and liquid paraffin is used as an emollient. Chamomile or calendulas are used as a softener of the compositions.

Said pharmaceutical composition may be in the form of gel, ointment, cream, spray or lotion. In general, the composition according to the first aspect of this invention may be formulated in the form of usual preparations. The preparations may additionally contain one or more of filler, extender, and binder, moistening agent, disintegrator, surface active agent and lubricant.

Niacinamide or niacin, extracted from Vitamin B3, has many biological activities such as that it is hypoglycemic, hypolipidemic, vasodilator, hepatoprotective, Anti-anginal and cancer-preventive which means it is a strong candidate for treating diabetes, high cholesterol, triglycerides, heart disorders, poor blood circulation and hence it prevents diabetes complications in eyes, heart, kidneys, sex dysfunction and diabetic foot. Galega officinalis is known to be hypoglycemic and has also diuretic properties. Phytochemical databases show that Berberis vulgaris to be hypoglycemic, anti-diabetic and hypolipidemic. According to present invention for a therapy method said composition and the device are used. It is known that electrostatic pulses stimulate acupuncture pressure points and improve blood flow which leads to blood glucose reduction. Also, it is known that to relax diabetic from stress, remove muscle tension and tiredness, there is a direct relation between stress and tension with blood glucose sharp rise.

According to the present invention the device is capable of applying a micro-current to the acupuncture and reflexological points of the patients shortly after the topical composition is creamed thereof. Micro-current is a therapy method that can reach into the cell, active cell, improve the cell's metabolism and circulation, and then enhance the reduction of blood sugar. The devices uses micro-current and through the negative electricity wave, removes the harmful free radical insides cells, restores normal metabolism. Micro-current improves lymphatic drainage which helps in removing toxins from the body. Moreover, inducing arterial, venous and lymphatic flow improves metabolism which leads to blood sugar reduction. It can improve penetration of internal cell membrane, adjust electric potential, purify blood, and stimulate synthesis of ATP (Adenosine Tri-Phosphate) by action of high voltage pulsating vibration. ATP is a very important result of metabolic systems, and is the main energy source in the body, and the increase of electrical potential makes the cells inside the body full of energy. With high voltage static effect, the device improves the permeability of cell membrane, increases alkaline calcium ion in the blood, reduces acidic inorganic phosphorus, making the alkalescent pH value in the blood, restore the original acid- base balance in the body. Especially the activation of gamma globulin strengthens the immunity of the body.

One of the purposes of this invention is to provide the therapy/stimulation device for enhancing or increasing the release of insulin in a diabetic patient by the use of ultrasound produced by at least one transducer. Ultrasonic transmission activates or excites the medication to increase its effectiveness in insulin therapy or diabetes treatment. The therapy device for performing treatment of diabetes mellitus can apply at least one of a micro-current or acoustic wave to the topical pharmaceutical composition on a human body. Said therapy device comprises means to select between operations of the micro-current or acoustic wave. The device can transmit acoustical energy from an ultrasonic generator, through the exterior surface of the skin of a patient where the pharmaceutical composition is applied especially on to the reflexological and acupuncture points, for the purpose of increasing the release of bio- functional compounds from a targeted organ. The stimulation device can apply microcurrent or ultrasound onto human skin to which the topical pharmaceutical composition of Claim 1 is applied for treatment of diabetes mellitus. Said stimulation device comprises a transducer for generating ultrasound, a voltage source, at least one output circuit, a frequency generator for producing alternating voltage and at least one high voltage pulse current (HVPC) output circuit. Frequency of the stimulation device falls within the range from lOhz to 1000 Hz. and micro-current of the stimulation device falls within the range from 3mA to 23mA.

The micro-current therapy uses micro-electricity to enhance the transfer of active ingredients to the cells; ingredients are deeply transported to their targeted zone and are more efficient. Electrotherapy applications for the treatment of conditions such as diabetic ulcer, neuropathy, carpal tunnel, arthritis, sports injuries, post-op swelling, pain management, and many more are well-known. Electrotherapy provided pain relief to approximately 85 percent of patients with peripheral neuropathy. Peripheral neuropathy is a complication that afflicts greater than 36 percent of people with type 2 diabetes. The device comprises a low-frequency therapeutic apparatus which aims at treating a disease by applying electrodes on the surface of the skin of a patient, and passing therewith a low-frequency current through the patient's body.

In a nutshell, firstly, the composition is used topically onto acupuncture and/or reflexological or acupuncture points of the patient then the stimulation device capable of applying micro-current combined with high voltage pulse current (HVPC) and ultrasound is used, together called as a therapy method. With the combination of the device the blood sugar concentration of diabetics can be effectively controlled, the complications of diabetics can be avoided, and the health of diabetics can be protected. The device has a voltage source and at least one high voltage pulse current (HVPC) output circuit. The HVPC output circuit has a transformer, a switching device, and a holding capacitor. One side of the transformer primary is connected to one side of the voltage source, and the switching device selectively connects the other side of the transformer primary to the other side of the voltage source for a preselected period of time. The holding capacitor is operatively connected to the transformer secondary, and an HVPC output is connected across the holding capacitor for having leads electrically connected thereto for attachment to the body of the patient. The device provides a train of HVPC pulses. Each HVPC pulse comprises first and second voltage spikes spaced by a preselected time period, and each HVPC pulse in the train occurs at a preselected frequency. Said device also have a frequency generator unit. The frequency generator unit comprises a frequency generator for producing alternating voltage, a first electrode output for connecting a first electrode, and a second electrode output for connecting a second electrode. The frequency generator has a voltage output, to which the alternating voltage produced by the frequency generator is applied.

Said device is designed to work with micro-current ranging, but not limited to, between 3mA and 23mA and voltage ranging, but not limited to between 22.6 to 88 volts and work on both AC and DC current. Frequency ranges are preferably between 10 to 1000 Hz.

Ultrasonic sensors are recently started to be used for the treatment of diabetes. The device includes several modules integrated to treatment for diabetes. The device can also use acoustic waves to vibrate fattiness cells, produces countless vacuum air pocket in and out of cells, mightily impacts the fatty cells, makes the cell membrane produce the inner cracking, so as to dissolve the triglyceride to be the glycerin and free fatty acid, then under the power of vacuum, to exhaust them out through the liver sausage circulation, at last, uses the dynamical photon and the oriented electrode to do skin tightening, gets the body slimming and weight loss. The force of the acoustic waves shatters and destroys the cellulite-causing connective fibers "The waves break down the fibrous walls to release clogged fat, water and toxins. Subjecting the tissue to acoustic waves creates an analgesic effect which stimulates the islets cells to produce insulin normally, this also reduces the islets cells inflammation when combined with HVPC electrostatic therapy and can stimulate repair of damaged beta cells which are responsible of producing insulin in the pancreas. The wavy combination of acoustic therapy with HVPC-electrostatic therapy forms an excellent and fast treatment for both types of diabetes together with consequences resulting from diabetes using an herbal composition at the same time. Even it is obvious that there is a synergic effect between composition and the device; the composition and device can be used separately.

The following examples are set forth to assist in understanding the invention but are not intended to, and should not be construed to; limit in any way the invention as defined by the claims which follow. Significant lowering of blood glucose was manifest within 30 minutes and persisted for at least 24 hours. The effect was dose dependent, and session-period dependent. For 10-30 minutes 3 times daily to treat type 1 and 2 of diabetes together with consequences resulting from diabetes in eyes, heart, kidney, feet, blood circulation and nervous system for 3-6 month course.

Case 1:

First patient was a 72 year old female with poorly controlled non-insulin- dependent diabetes, hypertension, and hypercholesterolemia. She was on insulin and metformin for more than 10 years. She started using composition without device 9 months ago. Her blood sugar was improved and HbAlc was dropped from 9.9 before treatment to 7.8, 6.6, and 5.8 during 9 months after commencement of treatment. The patient eventually stopped insulin and metformin gradually. Her HbAlc remains below 6 on diet alone. She used composition once and her glucose reading dropped from 195 to 83 within 30 minutes.

Case 2:

The second patient was a 69 year old male with a long history of non-insulin dependent diabetes and hypertension. Diabetic neuropathy had affected his feet and he could not feel the shoe rubbing. A small superficial ulcer developed on his foot which became infected and he used the composition for his diabetic ulcer. He used the composition on reflexological points in his feet, acupuncture points in his hands and inside his umbilica for 3 months and his HbAlC dropped from 12.6 to 7.8 and he reduced amount of insulin. His condition rapidly improves once he added 10 minute- sessions with stimulation device. In one day his blood sugar dropped from 292 postprandial to 190 at bed time then his fasting blood sugar was 88 next morning and he quit insulin within one week only.. HbAlc dropped from 7.8 to 6.6 after treatment. Case 3:

A 70 year old female was diagnosed with hypertension, and Type 2 diabetes 8 years ago and her sugar was not controlled by oral medications hence her doctor asked her to switch to insulin together with metformin. She started to use composition 4 months ago and her HbAlC reduced from 11.2 to 7.1.

Case 4:

A 55 year old male with hypertension, hypercholesterolemia, hypothyroidism, and type 2 diabetes (NIDDM) was treated with stimulation device together with composition on his hands for 2 weeks only. His blood sugar dropped from 450 to 122 during 2 week- treatment and he is still using the device once daily and the cream 3 times on his umbilica.

Case 5:

67 year old male doctor diagnosed with hypertension and type 2 diabetes (NIDDM) was treated with stimulation device together with composition on his hands for 1 week only. His blood sugar dropped from 195 to 125 during 1 week treatment and he is still using the device once daily and the cream 3 times on his umbilica daily. Case 6:

A 50 year old female with type-2 diabetes (NIDDM) and hypercholesterolemia, was treated with composition on her hands, foot and umbilica for 6 months during which she quit insulin. Her HbAlC dropped from 11 to 5.5 and she is still using the cream. Case 7

A 22 year old male with type-1 diabetes (IDDM) was treated with composition on his hands, foot and umbilica for 6 months during which he quit insulin. His HbAlC dropped from 10 to 6 and he is still using the cream and his c-peptide blood test increased from 0.6 to 2.5 within the first 3 months which means a regeneration of pancreatic beta cells and big increase in their numbers to produce enough insulin.

Case 8:

A 25 year old male with type 1 diabetes (IDDM) suffering from the age of 12. He started to use composition on preventive basis. His c-peptide increased from 0.5 to 2.6, and his sugar HbAlC became normal within 3 months. Case 9:

A 28 year old female university student with type 1 diabetes (IDDM) started to use composition on preventive basis. Her c-peptide increased from 0.3 to 2.8 within 3- month course.

Case 10:

A 59 year old female with type 2 diabetes (NIDDM), hypertension, was treated with composition on feet and umbilica together with stimulation device for 1 week and her blood sugar dropped from 285 to 122.

Toxicity study performed on mice in the animal house showed that the composition is free of adverse effects especially on liver, kidneys, lipid and other body organs.

Those skilled in the art will appreciate that the present invention may be susceptible to variations and modifications other than those specifically described. It will be understood that the present invention encompasses all such variations and modifications that fall within its spirit and scope.

Claims

A topical pharmaceutical composition for treatment of diabetes mellitus comprising;

Vitamin B3 or extract thereof,

Galega officinialis or extract thereof, and

Berberis Vulgaris or an extract of the same.

A topical pharmaceutical composition according to claim 1 , wherein the amount of Vitamin B3 is from 0.50 to 10 % by weight of the total composition.

A topical pharmaceutical composition according to claim 1 , wherein the amount of Berberis Vulgaris is from 0.50 to 10 % by weight of the total composition.

A topical pharmaceutical composition according to claim 1 , wherein the amount of Galega Officinialis is from 0.50 to 10 % by weight of the total composition.

A topical pharmaceutical composition according to any of the preceding claims, further comprising one or more surface active agents.

A topical pharmaceutical composition according to any of the preceding claims, the composition further comprising: a) Ethoxylated Fatty Alcohols 5 - 10 % by weight

b) Liquid Paraffin 10 - 15 % by weight

c) Aloe Vera Gel 5 - 15 % by weight

d) Chamomile Extract 3 - 8 % by weight

e) Calendula Extract 5 - 10 % by weight

f) Perfume 0.1 - 1 % by weight

g) Euxyl K100 0.1 - 1 % by weight

h) Vitamin B3 0.1 - 10 % by weight

i) Galega officinialis 0.1 - 10 % by weight j) Berberis vulgaris 0.1 - 10 % by weight

k) Water Complementary amount

A topical pharmaceutical composition according to Claim 1, said topical pharmaceutical composition is in the form of a gel, ointment, cream, spray or lotion.

A stimulation device for applying micro-current or ultrasound onto human skin to which the topical pharmaceutical composition of Claim 1 is applied, for treatment of diabetes mellitus, said stimulation device comprising;

- a transducer for generating ultrasound,

- a voltage source,

- at least one output circuit,

- a frequency generator for producing alternating voltage and

- at least one high voltage pulse current (HVPC) output circuit, characterized in that,

- frequency of the stimulation device falls within the range from lOhz to 1000 Hz. and

- micro-current of the stimulation device falls within the range from 3mA to 23mA.

9) A stimulation device according to Claim 8, said stimulation device is an ultrasound generator. 10) A stimulation device according to Claim 8, said stimulation device is a microcurrent generator.

A stimulation device according to Claim 10, wherein the stimulation device further comprises at least one electrode for delivering the micro-current to the patient.

A stimulation device according to Claim 10, wherein the high voltage pulse current (HVPC) output circuit comprises a transformer, a switching device, and a holding capacitor. 13) A stimulation device according to Claim 8, wherein the stimulation device is applied on to the acupuncture and reflexological points of a human body.