A Randomized, open-label, parallel-group, active controlled clinical study to evaluate the safety and efficacy of a Unani formulation compared with Metformin in patients with Dhayabitus Harr [Type 2 Diabetes Mellitus (G-2)]

Study RationaleThe Unani System of Medicine focuses on prevention through lifestyle modification dietary management and prophylactic interventions and enhances the immune system to fight against any disease. No specific drug is available for diabetes mellitus instead the drug is used to control the glucose level in the body and manage signs and symptoms of diabetes mellitus. The most commonly used drugs are Oral Hypoglycaemic Drugs (OHD) such as Sulphonylureas (SUs) and Biguanides (BGs). However these drugs have several adverse effects, and long term use of these drugs accumulate adverse effects that may be life threatening and in most cases affect the patient’s quality of life. The Unani drugs are natural and well tolerated by the body and produce fewer side effects than synthetic drugs. Several single and compound formulations are mentioned in the Unani literature which may maintain the body’s blood glucose level and vis-a-vis improve life quality. Therefore Unani formulations with ingredients having hypoglycemic activity may prove beneficial in the effective management of Diabetes mellitus, type 2.