Effect of a Novel Phytopharmaceutical Formulation with an Innovative Potential in Patients with Treated Uncontrolled Type 2 Diabetes Mellitus
Abstract
Background and Aims: Diabetes mellitus is a major health problem in India. The development of a new drug of natural origin that assures safety with moderate but definite efficacy is the need of the time. Authors have developed formulation containing phytoactives from Pterocarpus marsupium Roxb and Andrographis paniculata Nees in specific proportion for the first time, as an anti-diabetic supplement which improves the glycemic control. We aim to study the effect of PtyroneTM in patients with treated uncontrolled T2DM and its safety and tolerability.
Study Design: In an open labelled trial, 115 patients with T2DM were divided in three groups: Metformin, Metformin + Gliptins and Metformin + Sulphonylurea. PtyroneTM capsules were given to all the patients along with their OHA’s, orally twice a day for 12 weeks. Laboratory investigations were studied at the baseline and at fixed intervals till the end of the study.
Results: There was a statistically significant decrease (p value< 0.0001) in fasting and post prandial blood sugar along with triglycerides in all groups. There was reduction in levels of glycosylated haemoglobin also in all the groups. All other biochemical -investigations were within normal limits. PtyroneTM capsules were well tolerated clinically and no serious adverse -events were reported during the period of therapy.
Conclusion: The authors have shown, for the first time, the therapeutic potential of PtyroneTM at a dose of 450 mg twice a day supplemented along with anti-diabetic medications. This therapeutic efficacy needs to be evaluated further in a larger sample size, with a placebo/active controlled randomized double blind multicentric trial.
Clinical Trial Registration No.: CTRI/2019/05/019446
Conflict of Interest: Dr. Yogesh Dound is Proprietor of Shreepad Shree Vallabh, SSV Phytopharmaceuticals
Source of Support: The study was funded by Shreepad Shree Vallabh, SSV Phytopharmaceuticals.
References
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