A RANDOMISED SINGLE BLIND ACTIVE CONTROLLED, PARALLEL GROUP STUDY COMPARING THE EFFICACY & SAFETY OF THE KARNIM PLUS® CAPSULES IN PATIENTS WITH MILD OR MODERATE DIABETES MELLITUS TYPE. II

Abstract

Diabetes is the most prevalent disease in the world affecting middle and old aged persons of the world directly impacting their life style and other metabolic hazards. Karnim plus is a remedy of Unijules Life Sciences ltd. And current multicentric, randomized, single blind, active controlled and parallel group with metformin capsule clinical study is conducted in two centres of Dr. D.Y. Patil College and Ashwin Ayurved college respectively. Total 121 patients were treated according to the previously approved protocol from institutional ethics committee for the treatment period of 24 weeks in a dose of 2 capsules BID before meal and primary efficacy parameters set to HbA1c, fasting and post meal blood sugar. From the study it was concluded that Karnim plus capsule and Metformin capsule are equally effective in controlling hyperglycemia with slightly more time to achieve significance result in Karnim plus. In case of HbA1c highly significant results were observed in Karnim plus capsule and also highly significance is observed in symptom score of clinical parameters. Cholesterol levels are significantly decreased in Karnim plus group than metformin group. This indicated that Karnim plus is effective remedy in controlling diabetes type II with no any adverse effects and controlling metabolism in a effective way than other OHA.