Title of the invention

Supplement effect of Cherukurinja (Gymnema lactiferum) on glycemic control and on selected biochemical and physiological parameters among patients with type II diabetes mellitus.

Technical Field

The present invention relates to herbal nutrition product which is used as a food supplement made from dry leaf of Gymnema lactiferum and its use in helping the better glycemic control, control of hyperlipidemia, control of blood pressure and also reduction in the body weight among the type II Diabetes mellitus patients.

Background art

Most of the allopathic drugs which are used to control diabetes, failed to be free from complications and side effects and also not even be able to reach the proper control of plasma glucose level in diabetic patients. Therefore Medical science is still waiting for the better medication for proper control of Diabetes and prevention of its complications. This provides a room for alternative medicines in the treatment of diabetes

Most of the diabetes patients in Asian countries are using natural remedies in addition to allopathic drugs such as fenugreek, Gymnema, Bitter gourd, Cinnamon ect, with or without consulting the medical officers. Most of them have no any scientific evidence of the effectiveness and not even proved to be free from any harmful side effects. From ancient period Gymnema lactiferum has been used by Diabetic patients as food supplement. The primary use of this plant species is for adult onset diabetes (type 2). Several studies had been carried out to see the relationship between Gymnema sylvestre and Diabetes mellitus in animals as well as in human and one study was with Gymnema lactiferum in the past.

One of the study with animals showed that with the administration of Gymnema sylvestre increases the number of beta cells and some other studies showed increase in the serum insulin level.

Obesity is an important cause for the development of diabetes and it further complicates the proper management of blood sugar. Reducing the body weight is also an important part in the management of Diabetes. Some of the studies with Gymnema sylvestre show that it will help to reduce the body weight. It will further help for the better control of diabetes.

None of the above mentioned studies have been designed in the proper way up to meet the international standard with adequate sampling. Therefore I am planning this randomized double -blind controlled clinical trial with Gymnema lactiferum Herbal Tea as a food supplement in Diabetic patients from Diabetic center in TH Jaffna. If we are able to complete the task of this clinical trial and the results are favorable, the Gymnema lactiferum herbal tea would be a great boon for the treatment of diabetic patients in the future.

Technical problem

Diabetic Mellitus affect the metabolism of carbohydrate, proteins, and fats. It is associated with irreversible structural changes in the cells of the vascular system which leads to Complications of Skin, Complications of Eyes, Neuropathy, Diabetic Foot Ulcers, DKA (Ketoacidosis) & Ketones Kidney Disease (Nephropathy), High Blood Pressure (Hypertension), Stroke Hyperosmolar Hyperglycemic Non ketotic Syndrome (HHNS), Gastroparesis, Heart Disease, Mental Health and Pregnancy Related Conditions. Fifteen percent of diabetics develop foot ulcers during their life time with significant health related decrease in quality of life and consumption of a great deal of healthcare resources, while diabetic foot ulcers account for between 50% to 80% of non traumatic amputations. Most of the patients get Diabetic Neuropathy and Nephropathy later in the life.

Most of the allopathic drugs which are used to control diabetes failed to be free from the above complications and side effects and also not even be able to reach the proper control of plasma glucose level in diabetic patients. Therefore Medical science is still waiting for the better medication for proper control of Diabetes and prevention of its complications. This gives the room for alternative medicines in the treatment of diabetes.

Technical Solution

Regular intake of one cup of Herbal tea made from Gymnema lactiferum per day in addition to their conventional drug will help in better glycemic control, control of hyperlipidemia, reduction of blood pressure and reduction in the body weight. Proper control of blood sugar and hyperlipidemia will help to prevent the complications of diabetic mellitus.

Brief description of drawings

Fig.l

Healthy leaves from the Gymnema lactiferum plants will be plugged by hand and dried under hygienic conditions under the hot sun for one day. Then these leaves are dried at 100 degree centigrade temperature for about 15 to 20 minutes. The leaves are rolled in order to disrupt their cell walls, enhancing the release of leaf moisture. Rolling time may vary from ten minutes to one hour depends on the method used- by hand rolling or machine rolling. Finally the rolled leaves are dried at 60 to 80 degree centigrade temperature for three days or until it is dried thoroughly. Then dried leaves would be ground to make like tea dust. After that they will be handed over to a tea packing company to pack as 1.5 gram of the herbal tea in tea bags.

Fig.2

The teas (Gymnema lectiferum herbal tea / Green Tea) will be prepared by dipping one tea bag in to a boiled cup of water and stirring for 5 minutes and be left to cool down.

Fig-3

Total of 320 patients will be selected randomly from the patients who are coming to the Diabetic Center at TH Jaffna. Then these patients will be divided into two equal groups randomly and one group will be provided one cup of Gymnema lectiferum Herbal tea and other group will be given one cup of green tea( Cc/meZZ/h sinensis )as active control in addition to their conventional drugs on once daily basis. The tea will be given for the first 3 months. FPG (Fasting plasma glucose) will be analyzed at the beginning of the research and at the end of the first three months in order to see the control. HBAiC will be analyzed at the beginning and at the end of the third month. At the end of the sixth month FPS and HBAiC will be done again to see for any hanging effects. Lipid profile will be analyzed at the beginning of the research, at the end of the three month and end of the sixth month to see the effect. Blood pressure and body weight will be measured at the beginning of the research, at the end of the first three months and end of sixth month. Full blood count, Serum creatinine, ALT, AST will be performed at the beginning and end of first, second, third and sixth months to look for any toxic effects. Every patient will be analyzed for six months period and total duration of the research will be one year.

Advantageous effects

Diabetic Mellitus affect the metabolism of carbohydrate, proteins, and fats. It is associated with irreversible structural changes in the cells of the vascular system which may end up with complications in Skin, Eyes, Neuropathy, Diabetic Foot Ulcers, DKA (Ketoacidosis) & Ketones Kidney Disease (Nephropathy), High Blood Pressure (Hypertension), Stroke, Hyper osmolar Hyperglycemic Nonketotic Syndrome (HHNS), Gastroparesis, Heart Disease, Mental Health and Pregnancy Related Conditions. Fifteen percent of diabetics develop foot ulcers during their life time with significant reduction of health related quality of life and consumption of a great deal of healthcare resources, while diabetic foot ulcers account for between 50% to 80% of non- traumatic amputations. Most of the patients are affected by Diabetic Neuropathy and Nephropathy later in the life. Most of the allopathic drugs which are used to control diabetes failed to be free from complications and side effects and also not even unable to reach the proper control of plasma glucose level in diabetic patients. Therefore Medical science is still longing for the better medication for proper control of Diabetes and prevention of its complications. This provides room for the alternative medicines in the treatment of diabetes. Most of the diabetic patients in Asian countries consume natural remedies in addition to allopathic drugs with or without consulting the medical officers. Without a proper scientific research, patients are taking the Gymnema lactiferum as a herbal remedy for diabetes mellitus. There was an actual need to prove the effects of Gymnema lactiferum in diabetes and any adverse effects of it through a properly designed scientific research. If we are able to find out favorable results by this research we shall recommend this herbal tea to every type II Diabetes mellitus patients.

Mode for invention

In this randomized double -blind controlled clinical trial we like to see the supplementary effect of Gymnema lactiferum herbal tea on glycemic control among Type II diabetic patients who are on oral conventional drugs. At the same time we like to analyze the effect on blood pressure, lipid profile and body weight in the above patients. 320 patients with type II diabetes mellitus who are on oral conventional drugs will be selected randomly from the patients who are coming to the Diabetic Center at TH Jaffna. Then these patients will be divided into two equal groups randomly and one group will be provided one cup of Herbal Tea made from Gymnema lectiferum dry leaves (Treatment group). The Tea is named as Gymnema Herbal Tea. Other group will be given one cup of green tea (Camellia sinensis) as active control in addition to their conventional drugs on once daily basis (Control group). The teas will be given for the first 3 months. FPG (Fasting plasma glucose) will be analyzed at the beginning of the research and at the end of the first three months in order to see the control. HBA1C will be analyzed at the beginning and at the end of the third month. At the end of the sixth month FPS and HBA1C will be done again to see any hanging effect. Lipid profile will be analyzed at the beginning of the research, at the end of the three month and end of the sixth month to see the effect. Blood pressure and body weight will be measured at the beginning of the research, at the end of the first three months and end of the sixth month. Full blood count, Serum creatinine, ALT, AST will be performed at the beginning and end of first, second, third and sixth months to look for any toxic effect. Every patient will be analyzed for six months period and total duration of the research will be one year.

Industrial Applicability

Gymnema lactiferum is a woody climber which belongs to the family of Asclapiadaceae distributed through out of India, Malaysia and Sri Lanka in dry forest. The leaves of the Gymnema lactiferum have been used as a leafy vegetable in northern part of Sri Lanka mainly by Diabetes mellitus patients for several decades. It is an easily growing tree found in all part of Sri Lanka. We will be able to cultivate it in massive amount to make the Herbal Tea for diabetic patients.

Number of people with type 2 diabetes is increasing in every country day by day. The number has risen from 108 million in 1980 to 422 million in 2014. By 2035, 592 million people will be affected by diabetes. Then this herbal tea will have a high demand in future among the diabetic patients.