Efficacy of integrated ayurveda treatment Protocol in uncontrolled type 2 diabetes Mellitus-a randomised controlled clinical trial

Abstract

1.1 ABSTRACT Introduction: Type 2 Diabetes Mellitus (T2DM) is a metabolic condition characterized by insulin resistance and pancreatic β-cell dysfunction caused by uncontrolled hyperglycaemia. There is also a link of inflammation in the pathogenesis of T2DM. T2DM is a growing concern worldwide, having reached epidemic proportions in many developing and most developed countries. According to American Diabetes Association, uncontrolled T2DM is measured as a glycated hemoglobin level (HbA1C) of >7%. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke, and lower limb amputation. In 2016, an estimated 1.6 million deaths were directly caused by diabetes. Another 2.2 million deaths were attributable to high blood glucose in 2012. Almost half of all deaths attributable to high blood glucose occur before the age of 70 years. WHO estimates that diabetes was the seventh leading cause of death in 2016. The treatment of T2DM begins with a thorough and interdisciplinary strategy. The American Diabetes Association's (ADA) treatment guidelines emphasize medical nutrition therapy, exercise, pharmaceutical therapy, and the prevention and control of diabetes-related complications. ADA recommends, metformin is the only medicine shown in randomized controlled trials (RCTs) to reduce mortality and complications. Additional drugs should be introduced in a patient-centred, customized manner, although there is no evidence from RCTs that any of these medications lower the risk of diabetes-related complications, cardiovascular mortality, or all-cause mortality. A 2011 comparative efficacy evaluation found that metformin, second-generation sulfonylureas, thiazolidinediones, and repaglinide (Prandin) reduced A1C levels by roughly 1% when used alone, and that combination therapies had an additive effect on A1C levels. Medications used to manage type 2 diabetes have a variety of negative effects such as nausea, diarrhoea, xxix

abdominal bloating, weight loss or gain, and hypoglycaemia etc. Insulin therapy should be initiated if a patient fails to achieve glycaemic goals, is used as an initial treatment for type 2 diabetes in metabolic decompensation, or in cases of decompensated renal or hepatic insufficiency, myocardial infarction, stroke, acute severe illness, or major surgery. Ayurveda classics describe the etiological factors of Prameha as sedentary activities, early introduction of milk and its products, animal feed cultivated especially in swampy areas, newly harvested grains, and refined sugars, etc., which have more similarities with the aetiology of T2DM. Ayurveda classics defines Prameha as a set of complex clinical disorders characterized by frequent abnormal micturition, with the etiology involving genetic predisposition as well as improper diet and lifestyle. The clinical conditions described in prameha have much in common with diabetes mellitus. Ayurveda recommends different treatment modalities in prameha such as nidana parivarjana (preventive strategies), shodana (Detoxification), shamana (internal medication) and pathyapathya (diet and lifestyle restriction). Integrated medicine (also known as integrated medicine) is the practice of strategically incorporating parts of complementary and alternative medicine into complete treatment strategies. Integrated medicine through complementary and alternative medicine (CAM) or "complementary health approaches" is a range of different medical and health-care techniques and products that are not now regarded to be part of traditional medicine. These include, yoga, chiropractic and osteopathic manipulation, meditation, massage therapy, acupuncture, relaxation techniques, tai chi, qi gong, healing touch, hypnosis, and movement therapies are some of the xxx options. Other complementary health approaches include traditional healers, Ayurvedic medicine, traditional Chinese medicine, homeopathy, and naturopathy. Researchers are currently exploring the potential benefits of integrative approach in a variety of medical conditions including pain management, different neurological conditions, cancer symptoms and treatment side effects, cardiology etc. Integrative approach can be beneficial in T2DM because most of which involve self- management, healing approaches and lifestyle changes. Ayurveda herbs have insulin sensitivity, anti-hyperglycemic, anti-hyper lipidemic, antioxidant properties etc. have beneficial effects in T2DM. Ayurveda dietetics have positive results in insulin resistance. Yoga (which includes Surya namaskar, Asanas, pranayama, and meditation) has proven a successful complimentary alternative in T2DM. Objective: Primary Objective: To evaluate the efficacy of Integrated Ayurveda treatment protocol as add-on therapy in patients of uncontrolled T2DM in achieving the glycemic control assessed through HbA1C