Randomized Controlled Clinical Trial Of Add On Effect Of Kutajadi Tablet Along With Glimepiride-Metformin In Diabetes Mellitus - II

Diabetes mellitus is a group of metabolic disorders characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action, or both. India ranks second globally, after China, in terms of the number of individuals affected by diabetes mellitus, making it a major public health concern. Type 2 diabetes mellitus (T2DM) has emerged as a significant global health challenge and is expected to remain so due to its chronic nature and potential for serious complications.

According to the National NCD Monitoring Survey (NNMS), the prevalence of diabetes in India was reported to be 9.3% in 2018. Similarly, the International Diabetes Federation (IDF) estimated a prevalence of 9.6% in 2021, with projections indicating a rise to 10.4% by 2030. Along with increasing prevalence, the incidence of diabetes is also steadily rising, placing India among the leading nations affected by this metabolic disorder. The growing burden of diabetes poses significant challenges to healthcare systems and adversely affects the quality of life of individuals. In Ayurveda, Prameha is one of the most elaborately described diseases in classical texts and is considered a major metabolic disorder. It is categorized under Mahagada (a group of grave diseases) due to its chronicity, complexity, complications, and involvement of multiple body systems, particularly the urinary system. The clinical features of Prameha show close resemblance to diabetes mellitus described in modern medicine.

Kutajadi formulation, explained in Chikitsa Sthana of Sushruta Samhita, has been selected for the present study. This classical polyherbal formulation is mentioned to possess Pramehaghna (anti-diabetic) properties in various Ayurvedic texts. Kutajadi Tablet contains herbs predominantly having Tikta and Kashaya Rasa, which play a significant role in correcting Meda Dhatu Dushti and improving metabolic balance. These pharmacodynamic properties suggest its potential in the management of Prameha and related metabolic disorders.Prameha, as described in Ayurveda, can be correlated with diabetes mellitus in contemporary medical science. This metabolic disorder predisposes individuals to chronic microvascular complications such as neuropathy, retinopathy, and nephropathy, as well as macrovascular complications including myocardial infarction and stroke. Classical symptoms of Prameha such as Prabhuta Mutrata, Avila Mutrata, and Pipasa Adhikya closely correlate with polyuria, turbid urine, and polydipsia seen in type 2 diabetes mellitus. In recent times, sedentary lifestyle, lack of physical activity, and improper dietary habits have significantly contributed to the rising prevalence of type 2 diabetes mellitus. Long-term use of synthetic antidiabetic drugs is often associated with adverse effects such as hypoglycemia, weight gain, and gastrointestinal disturbances. Hence, there is a growing need for safer and effective complementary therapies. The present study aims to evaluate the add-on effect of the classical Kutajadi Tablet in the management of type 2 diabetes mellitus. This formulation is described in Prameha Chikitsa (Chikitsa Adhyaya 11, Shloka 8) of Sushruta Samhita and is believed to possess potential antihyperglycemic properties. The study intends to explore its therapeutic efficacy as a complementary approach in the management of diabetes mellitus type 2.

Study time - 90 days

Follow up - 0, 30, 60, 90

Total duration of study - 18 months