Efficacy and safety of Mamajjaka Ghanavati in the treatment of type-2 diabetes mellitus: a prospective open label multi-center clinical study

Abstract

Background and objectives: The purpose of this study is to investigate the efficacy and safety of Mamajjaka Ghanavati on blood glucose level, symptoms, and quality of life in patients with type 2 diabetes mellitus. Subjects and methods: This prospective, multi-center, open-label, single-arm clinical study was performed at three peripheral institutes of the Central Council for Research in Ayurvedic Sciences, New Delhi during April 2016 to May 2017. A total of 177 eligible patients with type 2 diabetes mellitus were included and administered Mamajjaka Ghanavati two tablets (500 mg each) twice daily after food for 84 days. At the end of the treatment period (84th day), the changes in Diabetes Symptom Questionnaire (i.e., glycosylated hemoglobin and fasting and postprandial blood sugar levels) were analyzed. Quality of life was evaluated using 36-Item Short Form Health Survey (SF-36). Clinical safety of Mamajjaka Ghanavati was assessed by liver and renal function tests. This study was approved by the Medical Ethics Committee of Central Council for Research in Ayurvedic Sciences, New Delhi (approval number: CTRI Reg No Ref/2016/06/011468) on March 14, 2016. Results: Compared to baseline data, after 84 days of treatment with Mamajjaka Ghanavati, Diabetes Symptom Questionnaire score was significantly decreased, and SF-36 score was significantly increased (both P Conclusion: Mamajjaka Ghanavati can greatly improve the quality of life and is safe in the treatment of type 2 diabetes mellitus. Actually, Mamajjaka Ghanavati does not change blood sugar level greatly. Trial registration: This study was registered in the Clinical Trial Registry of India (CTRI/2017/09/009887) on September 22, 2017.