A randomized, parallel group, open label, active controlled clinical study to evaluate safety and efficacy of Dawa-i-Dhayabitus in Dhayabitus Harr Qism Thani (Diabetes Mellitus Type 2)

As per the WHO, diabetes mellitus is defined as a heterogeneous metabolic disorder characterized by common feature of chronic hyperglycemia with disturbance of carbohydrate, fat and protein metabolism.

Diabetes Mellitus is a leading cause of morbidity and mortality world over. It is expected to continue as a major health problem owing to its serious complications, especially end stage renal disease, IHD, gangrene of the lower extremities, and blindness in the adults. The rise in prevalence is more for Type 2 DM than Type 1DM.

Diabetes is a major health issue that has reached alarming levels. Today, more than half a billion people are living with diabetes worldwide. According to IDF Atlas in 2021, it is estimated that 537 million people have diabetes, and this number is projected to reach 643 million by 2030, and 783 million by 2045. In addition, 541 million people are estimated to have impaired glucose tolerance in 2021. Direct health expenditures due to diabetes are already close to one trillion USD and will exceed this figure by 2030.

Despite of advances in the treatment of Diabetes Mellitus, it becomes the major epidemic among NCDs. Treatment for diabetes mellitus includes insulin therapy and oral antidiabetic drugs. Oral anti-diabetic drugs include sulphonylureas(glimepiride, gliclazides), biguanides (metformin), thiazolidinediones(pioglitazone), DPP-4 inhibitors (sitagliptin, vildagliptin), and SGLT2 inhibitors (dapagliflozin), but these drugs have certain adverse effects, such as abdominal discomfort, nausea, vomiting, diarrhea, weight gain.[3,4] Therefore, search of safe and effective drug for Diabetes Mellitus is the thrust area for research in medical fields.

Unani system of medicine (USM) offers treatment for Diabetes Mellitus type 2. Many classical prescriptions comprising single herbo-mineral drugs and pharmacopoeial formulations have been recommended for the management of diabetes mellitus type 2, which are safe and cost effective, such as Qurá¹£-i-TabāshÄ«r,Qurá¹£-i-Kafoor, Qurá¹£-i-DhayābÄ«á¹­us, SafÅ«f DhayābÄ«á¹­us, Qurá¹£-i-Gulnār, KushtaBaidha Murgh. Some of these drugs mentioned in Unani classical literature have not been explored scientifically regarding their safety and efficacy. Dawā’-i-DhayābÄ«á¹­us is one of the compound formulations described by physicians in classical Unani literature for the management of DhayābÄ«á¹­us á¸¤Ärr, but its safety and efficacy has not been evaluated on scientific parameters. Therefore, present clinical trial entitled â€œA Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Dawā’-i-DhayābÄ«á¹­us in DhayābÄ«á¹­us á¸¤Ärr Qism ThānÄ« (Diabetes Mellitus Type 2)” has been planned.