Ayurvedic polyherbal combination (PDBT) for prediabetes: A randomized double blind placebo controlled study

BACKGROUND: Increasing prevalence of type 2 diabetes mellitus (DM) has become alarming, burdening health care systems throughout the world. Prediabetes is an intermediate step before manifestation of full blown DM. Effective intervention at this step would help stop/slow progression to DM. OBJECTIVE: This study aimed at use of a polyherbal combination (PDBT – constituted of Tinospora cordifolia, Pterocarpus marsupium, Gymnema sylvestre, Zingiber officinale and Momordica charantia) along with life style modification compared to a placebo in prevention of DM among prediabetic individuals. MATERIALS AND METHODS: The study was a double blinded, placebo controlled randomized clinical trial. Participants were divided in to a group on PDBT and life style management (LSM) and second on placebo and LSM. Participants in the intervention group received 2 gm/day of PDBT. All participants received the intervention for a period of 6 months. RESULTS: One hundred and fourteen participants were enrolled in the study, 57 each in intervention and control group. At the end of the study, 8 participants from the intervention group, compared to 15 participants in the control group had converted to DM. There was a 47% risk reduction in the intervention group. Participants in the intervention group showed statistically significant decrease in their blood glucose level (fasting and PP), HbA1c, fasting serum insulin and HOMA-IR values. There was no significant change in BMI. No adverse effects were reported by any participants. CONCLUSION: PDBT along with LSM in prediabetic participants was associated with reduction in conversion to DM than placebo along with LSM without any adverse effects.