A Polyherbal Indian System of Medicine (Ayush) Preparation for Optimization of Glycemic Control in Newly Diagnosed Type 2 Diabetes and Prediabetes; A Multicenter, Randomised, Double-Blind, Placebo- Controlled Trial

Background: Current therapeutics do not provide optimized care in early stage type 2 diabetes and there is no established treatment for prediabetes. We did a randomised trial to assess the efficacy and safety of a popular Ayush product, Sugar Balance ® (sugar balance) in patients with newly diagnosed type 2 diabetes and prediabetes. Methods: In this multicentre, double blind placebo-controlled trial, we randomly assigned (1: 1) eligible participants, 30 years of age or older, of either gender and diagnosed with type 2 diabetes (HbA1c ≥ 6.5%) or prediabetes (FPG ≥ 5.6 mmol/L). We used computer-generated ramdomisation, stratified by type of diagnosis (prediabetes or diabetes). Active recipients were to receive 250 mg capsules containing 3 Organic certified whole herbs : Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle (sadabahar). The recommended dose was 2 capsules twice daily. The primary outcome was ≥0.5% reduction in HbA 1c for type 2 diabetes subjects and an increased incidence of normalization in impaired fasting blood glucose for prediabetes subjects at 6 months after randomization. The primary analysis included all subjects who received the allocated intervention and had 1 follow up visit after randomisation. All subjects received standard life style recommendations for diet and exercise. Type 2 diabetes subjects were allowed to be on biguanides (metformin) of their choice. This trial is registered with ClinicalTrials.gov, number NCT02866539 and clinical trials registry of India, number CTRI/2016/11/007435, and is completed. Findings: Between December 14 th 2016 and 28 th August 2017, 122 subjects were randomly assigned to active sugar balance (n=61) or matching placebo (n=61), of whom one subject (assigned to placebo) did not receive the allocated intervention. All follow up was completed on 16 th December 2017. At 6 months type 2 diabetes subjects allocated to active arm had a mean reduction of HbA 1c of -0.52% versus -0.43% among placebo arm (difference of -0.09% 95% CI -0.1705 - -0.0095). 13 (52%) versus 4 (15.4%) prediabetes subjects receiving the polyherbal achieved normalization of impaired fasting glycaemia (<100 mg/dl) (difference of 36.6% 95% CI 10.683 - 56.805). None of the study participants experienced significant hypoglycemia or significant changes in their safety clinical biochemistry parameters on therapy. Conclusions: Sugar Balance promises to be effective and safe supplement for type 2 diabetes subjects to achieve a better optimization of HbA 1c when taken along with standard dose of metformin and for prediabetes subjects to achieve their target fasting blood sugars with diet and exercise.