Background. Momordica charantia is a medicinal plant used traditionally for treatment of various diseases including diabetes. Objective. To evaluate the efficacy and safety of PDM011011 capsules (1.2 g/day) as an adjuvant thera py in subjects with type 2 diabetes mellitus (T2DM). Methods. Each PDM011011 capsule contained 400 mg dry fruit juice powder of Momordica charantia. Ninety three T2DM patients receiving at least one oral hy poglycemic treatment were screened. The eligible 85 subjects were randomized into 3:1 ratio in drug treatment (PDM011011 capsules) and placebo arm. Sixtyfour patients received three 400 mg PDM011011 capsules (1.2 g/day) while 21 patients received three placebo capsules per day for 90 days respectively. The primary efficacy endpoints were mean change in FPG, PPG level and HbA 1c % from baseline to day 30, 60 and 90 after interventions. Results. PDM011011capsule (1.2 g/day) showed sig nificant reduction in FPG level by 14.59% after 90 days treatment, while patients receiving placebo capsules exhibited a marginal increase of 2.12%. The reduction in FPG level was statistically significant (p = 0.013) as compared with the placebo group. It also reduced PPG level by 22.21% as compared to the 3.71% reduction (p = 0.002) in placebo group. The encouraging reduc tion in HbA 1c % in the drug group was 0.78 as compared to the placebo group with only 0.20 (p = 0.066). PDM011011 capsule showed no adverse events, seri ous adverse events and death in the study population. Conclusion. PDM011011capsule (1.2 g/day) showed good efficacy and safety; and it can be prescribed as an adjuvant therapy in subjects with T2DM.
IMPORTANCEWomen with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. OBJECTIVE To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. DESIGN, SETTING, AND PARTICIPANTS This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.