A herbal tea with beneficial effects on t2DM patients

Abstract

A specially prepared herbal tea (1.5 g) for patients with Type II diabetes mellitus is derived from Gymnema lactiferum leaves. This tea was utilized in a randomized, double blind, controlled clinical trial at the Diabetic Center, Teaching Hospital Jaffna, Sri Lanka. In this trial, participants were randomly divided into two groups: one group received one cup of herbal tea per day in addition to their conventional medications, while the other group received one cup of green tea as an active control for three months. Blood samples were analyzed according to the schedule outlined in the mode of intervention, which helped achieve better glycemic control in uncontrolled or poorly controlled diabetes, along with a decrease in total cholesterol, LDL cholesterol, and triglycerides. Blood pressure was reduced in patients with elevated blood pressure, and body weight decreased, with no significant reduction in HDL cholesterol among Type II diabetes mellitus patients.

Description

A Herbal Tea with Beneficial Effects on T2DM Patients

[0001] The present invention relates to a herbal nutrition product made from the dry leaf of Gymnema lactiferum (1.5 g). This product was used as a food supplement to help better control glycemic control, hyperlipidemia, blood pressure, and body weight among type II Diabetes mellitus patients.

[0002] Most of the allopathic drugs, that are used to control diabetes, fail to be free from complications and side effects and not even be able to reach the proper control of plasma glucose levels in diabetic patients. Therefore, Medical science is still waiting for better medication for the appropriate control of Diabetes and the prevention of its complications. This provides room for alternative medicines in the treatment of diabetes.

[0003] Most diabetes patients in Asian countries use natural remedies in addition to allopathic drugs, such as fenugreek, Gymnema, Bitter gourd, and cinnamon, with or without consulting medical officers. Most have no scientific evidence of their effectiveness and are not even proven free from harmful side effects. From the ancient period, Diabetic patients have usedGymnema lactiferumas a food supplement. The primary use of this plant species is for adult-onset diabetes (type 2). Several studies have been carried out to see the relationship betweenGymnema sylvestreand Diabetes mellitus in animals as well as in humans and one study was withGymnema lactiferumin the past.

[0004] One of the studies with animals showed that the administration of Gymnema sylvestre increases the number of beta cells and some other studies showed an increase in the serum insulin level.

[0005] Obesity is an important cause for the development of diabetes and it further complicates the proper management of blood sugar. Reducing body weight is also an important part of the management of Diabetes. Some of the studies with Gymnema sylvestre show that it will help to reduce body weight. It will further help for the better control of diabetes.

[0006] None of the above-mentioned studies has 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 withGymnema lactiferumHerbal Tea as a food supplement in Diabetic patients from the Diabetic center in TH Jaffna.

[0007] We completed the clinical trial and the results were published in Elsevier -Clinical Traditional Medicine and Pharmacology on 7 August. The Results of this study will be a great boon for the treatment of diabetic patients in the future.Technical Problem

[0008] Diabetic Mellitus affects the metabolism of carbohydrates, proteins. 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), Nephropathy, High Blood Pressure (Hypertension), Stroke, Hyperosmolar Hyperglycemic non-ketotic Syndrome (HHNS), Gastroparesis, Heart Disease, Mental Health and pregnancy related conditions. Fifteen percent of diabetes patients develop foot ulcers during their lifetime with significant health related, decreases in quality of life and consumption of a deal of healthcare resources, while diabetic foot ulcers account for 50% to 80% of non-traumatic amputations. Most of the patients get Diabetic Neuropathy and Nephropathy later in their life.

[0009] Most of the allopathic drugs, which are used to control diabetes, fail to be free from the above complications and side effects and not even be able to reach the proper control of plasma glucose levels in diabetic patients. Therefore, Medical science is still waiting for better medication for the appropriate control of Diabetes and the prevention of its complications. This gives room for alternative medicines in the treatment of diabetes.Solution to Problem

[0010] Regular intake of one cup of specially made herbal tea made fromGymnema lactiferum(1.5 g in a tea bag) per day in addition to their conventional drug helped to bring down the HbA1c in uncontrolled and poorly controlled diabetes without any episode of hypoglycemia (a better glycemic control), brought down the total cholesterol, brought down the LDL Cholesterol and triglyceride, no significant reduction in the HDL Cholesterol (good cholesterol), reduction of blood pressure in blood pressure elevated patients (Hypertensive Patients) without any episode of hypotension and reduction in the body weight. The above mentioned findings helped to prevent the complications of diabetic mellitus and help to control prediabetes (Metabolic Syndrome).

[0011] Diabetic Mellitus affects the metabolism of carbohydrates, proteins, and fats. It is associated with irreversible structural changes in the cells of the vascular system which may end up in complications in the Skin, Eyes, Neuropathy, Diabetic Foot Ulcers, DKA (Ketoacidosis) & Ketones Kidney Disease (Nephropathy), High Blood Pressure (Hypertension), Stroke, Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHNS), Gastroparesis, Heart Disease, Mental Health and Pregnancy-Related Conditions. Fifteen percent of diabetics develop foot ulcers during their lifetime with a significant reduction of health-related quality of life and consumption of a great deal of healthcare resources, while diabetic foot ulcers account for 50% to 80% of non-traumatic amputations. Diabetic Neuropathy and Nephropathy affect most of the patients later in life. Most of the allopathic drugs, that are used to control diabetes, fail to be free from complications and side effects and are not even able to reach the proper control of plasma glucose levels in diabetic patients. Therefore, Medical science is still longing for better medication for the proper control of Diabetes and the prevention of its complications. This provides room for alternative medicines in the treatment of diabetes. Most diabetic patients in Asian countries consume natural remedies in addition to allopathic drugs with or without consulting medical officers. Without proper scientific research, patients are taking theGymnema lactiferumas a herbal remedy for diabetes mellitus. There was an actual need to prove the effects ofGymnema lactiferumin diabetes and any adverse effects of it through properly designed scientific research. This requirement was met by this published clinical trial. Based on the findings, we can recommend this herbal tea to every type II Diabetes mellitus patient.Advantageous Effects of Invention

[0012] Diabetic Mellitus affects the metabolism of carbohydrates, proteins, and fats. It is associated with irreversible structural changes in the cells of the vascular system which may end up in complications in the Skin, Eyes, Neuropathy, Diabetic Foot Ulcers, DKA (Ketoacidosis) & Ketones Kidney Disease (Nephropathy), High Blood Pressure (Hypertension), Stroke, Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHNS), Gastroparesis, Heart Disease, Mental Health and Pregnancy-Related Conditions. Fifteen percent of diabetics develop foot ulcers during their lifetime with a significant reduction of health-related quality of life and consumption of a great deal of healthcare resources, while diabetic foot ulcers account for 50% to 80% of non-traumatic amputations. Diabetic Neuropathy and Nephropathy affect most of the patients later in life. Most of the allopathic drugs, that are used to control diabetes, fail to be free from complications and side effects and are not even able to reach the proper control of plasma glucose levels in diabetic patients. Therefore, Medical science is still longing for better medication for the proper control of Diabetes and the prevention of its complications. This provides room for alternative medicines in the treatment of diabetes. Most diabetic patients in Asian countries consume natural remedies in addition to allopathic drugs with or without consulting medical officers. Without proper scientific research, patients are taking theGymnema lactiferumas a herbal remedy for diabetes mellitus. There was an actual need to prove the effects ofGymnema lactiferumin diabetes and any adverse effects of it through properly designed scientific research. This requirement was met by this published clinical trial. Based on the findings, we can recommend this herbal tea to every type II Diabetes mellitus patient.Fig.1

[0013] Healthy leaves from theGymnema lactiferumplants were plugged by hand from the Herbal Garden. The leaves were selected again in the production place and washed with clean water two times to remove the dust from the leaves. Then the leaves dried under hygienic conditions under shadow for 3 days. These leaves were dried at a specific temperature of 100 degrees centigrade temperature for 2 hours. Then the leaves were rolled for 1 hour to disrupt their cell walls, enhancing the release of leaf moisture. Rolling time was one hour by hand rolling. Finally, the rolled leaves are dried at a specific temperature of 40 to 50 degrees centigrade temperature for three days or until it is dried thoroughly. The dried leaves were ground to make tea dust and they were packed as 1.5 grams of the herbal tea in tea bags.Fig.2

[0014] Three hundred twenty patients were randomly selected from those attending the Diabetic Center at TH Jaffna. Then these patients were divided into two equal groups randomly one group was provided one cup ofGymnema lectiferumHerbal tea and the other group was given one cup of green tea (Camellia sinensis)as active control in addition to their conventional drugs on once daily basis. The tea was given for the first 3 months. FPG (Fasting plasma glucose) was analysed at the beginning of the research and at the end of the first three months to see the control. HBA1C was analysed at the beginning and the end of the third month. At the end of the sixth month, FPS and HBA1C will be done again to see for any hanging effects. The lipid profile was done at the beginning of the research, at the end of the three months, 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, and AST were performed at the beginning and end of the first, second, third and sixth months to look for any toxic effects. Every patient studied for six months and the total duration of the research will be one year.

[0015] Gymnema lactiferumis a woody climber that belongs to the family ofAsclapiadaceaedistributed throughout India, Malaysia and Sri Lanka in dry forests. The leaves of theGymnema lactiferumhave been used as a leafy vegetable in the northern part of Sri Lanka mainly by Diabetes mellitus patients for several decades. It is an easily growing tree found in all parts of Sri Lanka. We will be able to cultivate it in massive amounts to make Herbal Tea for diabetic patients.

[0016] The 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.

Claims

A method of controlling blood sugar in Type II Diabetic Mellitus patients, consisting of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs bring down the HbA1c (long lasting control during the post intervention period of three months) in uncontrolled and poorly controlled diabetes without any episode of hypoglycemia (a better glycemic control) or any effect in Nomo glycemic patients.The method of controlling Total Cholesterol in Type II Diabetic Mellitus patients consisting of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs bring down the total cholesterol level (long lasting control during the post intervention period of three months).The method of controlling LDL Cholesterol in Type II Diabetic Mellitus patients consists of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs bring down the LDL Cholesterol level (long lasting control during the post intervention period of three months).The method of controlling Triglyceride in Type II Diabetic Mellitus patients consisting of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs bring down the Triglyceride level (long lasting control during the post intervention period of three months).The method of Keeping the HDL Cholesterol (Good Cholesterol) level despite bringing down the Total Cholesterol, LDL cholesterol, and Triglyceride levels in Type II Diabetic Mellitus patients consisting of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs bring help to maintain HDL Cholesterol (Good cholesterol) level without any significant reduction(long lasting effect during the post intervention period of three months).The method of controlling blood pressure in blood pressure elevated patients of Type II Diabetic Mellitus patients consists of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs help reduction of blood pressure (long lasting control during the post intervention period of three months) in blood pressure elevated patients (Hypertensive Patients) without any episode of hypotension or any change in the blood pressure in patients without hypertension.The method of reducing the body weight in Type II Diabetic Mellitus patients consisting of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs helps to reduce (long lasting control during the post intervention period of three months) the body weight.The method of preventing the complications of Type II Diabetic Mellitus patients consisting of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs helps to prevent the complications of Diabetes mellitus by controlling the major non-communicable diseases (Type II Diabetes mellitus), Hypercholesterolemia and Hypertension and also, reduce body weight and maintain good cholesterol (HDL) levels.A method of controlling prediabetes (Metabolic Syndrome) consisting of: One cup of herbal tea, specially made fromGymnema lactiferumleaves (1.5 g in a tea bag) was given to Type II Diabetes mellitus patients as a food supplement in addition to the conventional drugs helps to control prediabetes (Metabolic Syndrome).

Images