Background and objectives: Diabetes mellitus is a chronic metabolic disorder characterized by persistent hyperglycaemia. It may be due to impaired insulin secretion, resistance to peripheral actions of insulin, or both. Unani system claimed for the efficacy of many anti-hyperglycaemic drugs, and all such drugs required validated on scientifically. Hence a clinical study was intended to evaluate the clinical efficacy of the Unani formulation in the management of diabetes. Methods: This trial was conducted as single blind randomized standard control, on 60 patients of type 2 diabetes with the test (n =30) and control (n=30) groups for 45 days. Test group received Unani Formulation twice daily at a dosage of 5 g powder, and control group received 500 mg tablet metformin twice a day before meal. The subjective (at 0, 15th, 30th, 45th), and objective parameters were evaluated respectively as pre-post care. Results: After treatment with Unani Formulation significant reduction was observed in subjective parameters (viz. polyuria, polydipsia, polyphagia and tiredness) in connotation of control group. In both groups the objective parameters FBS, PPBS, and HbA1c were found to be significantly reduced. The findings were statistically analysed using paired and non-paired tests. Conclusion: Based on the above observation, it is concluded that there is substantial anti-diabetic effect of the Unani Formulation without any adverse drug reaction.