Efficacy and safety of Mamajjaka Ghanavati in the treatment of type 2 diabetes mellitus: A prospective open label multi-center clinical study
Malalur Nagesh Shubhashree1, Bikartan Das2, Gopal Chandra Nanda3, Gaddam Kumara Swamy4, Sarada Ota5, Shashidhar Doddamani1, Meda Mruthyumjaya Rao6, Vimal Tewari7, Baghwan Sahai Sharma5, Shruti Khanduri5, Rakesh Rana5, Richa Singhal5, Adarsh Kumar5, Narayanam Srikanth5
1 Technical Department, Regional Ayurveda Research Institute for Metabolic Disorders (RARIMD), Bengaluru, Karnataka, India
2 Technical Department, Central Ayurveda Research Institute for Hepatobiliary Disorders (CARIHD), Bhubneshwar, India
3 Technical Department, Dr. AchantaLakshmipati Research Centre for Ayurveda (DALRCA), Chennai, India
4 Technical Department, Central Ayurveda Research Institute for Neuromuscular & Muscular-Skeletal Disorders (CARINMSD), Cheruthuruthy, Kerala, India
5 Technical Department, Central Council for Research in Ayurvedic Sciences, New Delhi, India
6 Technical Department, Central Ayurveda Research Institute for Drug Development (CARIDD), Kolkata, West Bengal, India
7 Technical Department, Regional Ayurveda Research Institute for Infectious Diseases(RARIID), Patna, Bihar, India
Technical Department, Central Council for Research in Ayurvedic Sciences, New Delhi
Source of Support: None, Conflict of Interest: None
Clinical trial registration CTRI/2017/09/009887
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 < 0.01). However, compared to baseline data, no significant differences in glycated hemoglobin, fasting and postprandial blood sugar levels as well as hepatic and renal parameters were observed after 84 days of treatment with Mamajjaka Ghanavati.
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.