Diabetes mellitus is a major public health problem affecting millions of people worldwide. Available synthetic medicines have serious side effects, therefore, medicines of herbal origin have been widely used in therapeutic management of diabetes mellitus for a long time, and have received renewed attention of scientists globally. The present study envisages to evaluate the comparative efficacy and safety of a Unani coded drug UNIM-221 with an allopathic drug Metformin in diabetes mellitus type II cases. The data presented is a part of multicentric, randomized and open level clinical trials conducted on 32 UNIM-221and 44 cases on Metformin at