A Clinical Study to Evaluate the Efficacy and Safety of a Unani Formulation in the Management of Ziabetus Shakari (Diabetes Mellitus): A Randomized, Active Controlled, Parallel Group Clinical Trial

Dhayabitus Shakari (Diabetes mellitus) is a clinical syndrome of multiple etiologies characterized by an increase in plasma blood glucose (hyperglycemia) with disturbances of carbohydrate, fat, and protein metabolism. There are two main types of diabetes mellitus: type 1 and type 2. Type 1 diabetes is generally considered to result from autoimmune destruction of insulin-producing cells (β cells) in the pancreas, leading to marked insulin deficiency, whereas type 2 diabetes is characterized by reduced sensitivity to the action of insulin and an inability to produce sufficient insulin to overcome ‘insulin resistance’. Millions of individuals are affected by diabetes mellitus type II , which is the most common and rapidly progressing serious non-communicable disease in the world. Diabetes that has not been properly diagnosed results   in   various complications. Chronic hyperglycemia is responsible for diabetes-specific microvascular complications affecting the eyes (retinopathy), kidneys (nephropathy), and feet (neuropathy)1 and macrovascular complications include cardiovascular, cerebrovascular, and peripheral vascular disease.

The prevalence of diabetes has reached epidemic levels. Diabetes mellitus is rapidly becoming one of the most common non-communicable diseases. WHO reports diabetes mellitus as the ninth leading cause of death globally, accounting for 74% of global deaths in 2019. The International Diabetes Federation (IDF) reports that diabetes kills one person every seven seconds and kills about 3.2 million people every year worldwide. In India, there were 31.7 million individuals with diabetes overall in 2000, and 79.4 million are project to have the disease by 2030. Between 2000 and 2030, it is expected that the number of urban diabetics in emerging nations will double. Diabetes is predicted to kill 592 million people by 2035.

In the Unani system of medicine, physicians used various names for Dhayabitus, including Moattasha, Atsha, Zalaqul Kulliya, Dolab, Dawwarah, Barkar, Barkarya, and Qaramees. The various facts of diabetes mellitus have been well documented and addressed in unani classical Unani texts. Dhayabitus is a kidney disease, and it has been described as the patient passing the urine promptly just after taking water.  Ibne Sina termed it Zalaqul Kulliya. The etiopathogenesis of Dhayabitus Shakari in unani literature is based on Sue mizaj gurda (derangement in temperament), Zauf-e-kulliya (weakness of kidney) and Structural deviation (Ittasa-e- gurda). Many antidiabetic drugs found in Unani treasures are of natural origin. They are not only effective and potent in controlling glucose levels but also equally safe and less harmful than their modern counterparts. Various single (mufrad) and compound (murakkab) antidiabetic drugs like Maghze jamun, Methi, Satte gilo, Gulnaar, Tabasheer, Gil-e-armani, Tukhm-e- konch and Qurs-e- Kafoor, Qurs-e- Tabasheer, Qurs-e- Dhayabitus, Qurs-e-Gulnaar etc. are mentioned in unani literature.

Keeping the above facts in mind, the present study entitled "A Clinical Study to Evaluate the Efficacy        and Safety ofa Unani Formulation in the management of Dhayabitus Shakari (Diabetes Mellitus): A Randomized, Active Controlled, Parallel Group Clinical Trial” has been          designed. A polyherbal unani formulation in powdered form containing Tabasheer (Bambusa arundinacea), Gulnaar (Punica granatum), Gile Armini (Armenia Bole), Tukhm Khurfa (Portulaca oleracea) and Tukhm Kaahu (Lactuca sativa) is selected to evaluate its efficacy and safety in the management of Dhayabitus Shakari Qism Sani (Diabetes Mellitus type 2).