Validation of standardized polyherbal formulation in the management of type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial

Shridhar Pandya; Chetan Savaliya; Kamlesh Thummar; Amol Gothwad; Tanuja Panchabhai; Dheeraj Nagore

doi:10.1007/s40200-022-01171-4

Validation of standardized polyherbal formulation in the management of type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial

J Diabetes Metab Disord. 2022 Dec 22;22(1):495-506. doi: 10.1007/s40200-022-01171-4. eCollection 2023 Jun.

Authors

Shridhar Pandya¹, Chetan Savaliya¹, Kamlesh Thummar¹, Amol Gothwad², Tanuja Panchabhai³, Dheeraj Nagore⁴

Affiliations

¹ Gplife Healthcare Pvt Ltd, 705‑706, Orbit‑ 1 Building, Punagam‑Saroli Rd, Near RRTM Market, 395010 Surat, India.
² Lokmanya Medical Research Centre Lokmanya Hospital, Floor 4, OPD 1, 314/B Telco Road, Chinchwad, Pune, 411033 Maharashtra India.
³ Atharv Multispecialty Research Center, Krishna Chowk, Kirti Nagar, New Sanghavi, Pune, 411027 Maharashtra India.
⁴ Mprex Healthcare Pvt Ltd, 501, Crossroads Building, Bhumkar Chowk, Wakad, Pune, 411057 India.

Abstract

Background: Diabetes is prevalent globally; India stands amongst the first two countries with the highest percentage of adults aged 20-79 years with diabetes in 2021. Anti-diabetic agents and insulin offer profound side effects. Phytoconstituents regulate blood sugar, improve health status and reduce dependency on anti-diabetic medications. This research aims to generate clinical evidence of Diabetic Support Product (GP/PROD/2021/001) in the treatment of type 2 diabetes.

Trial design: A randomized, double-blind, placebo-controlled clinical trial was conducted on 150 individuals with type 2 diabetes mellitus. Subjects were divided into two parallel groups and given either GP/PROD/2021/001 or a placebo tablet; 2 tablets twice a day after meals for 90 days.

Methods: Interventions were adjuvant to the standard medication. The research objectives were to evaluate changes in fasting and post-meal plasma glucose and HbA1c in patients with type 2 diabetes.

Results: In 90 days, GP/PROD/2021/001 group showed a substantial improvement in all key biochemical markers-HbA1c, FBS, and PPBS when compared to the placebo group. A reduced HOMA-IR score suggests reduced insulin resistance. Quality of life improved in GP/PROD/2021/001 group than placebo. On day 90, there was a significant decrease in HbA1c levels in GP/PROD/2021/001 (23.51%) group than placebo (6.21%). The test group reduced their dependency on conventional antidiabetic medication and insulin.

Conclusion: It can be concluded from the study that the advanced diabetic support formula (GP/PROD/2021/001) is a safer and more effective option as an adjuvant in the management of diabetes from newly diagnosed to chronic diabetic patients.

Trial registration: CTRI/2022/01/039179 [Registered on: 05/01/2022] Trial Registered Prospectively.

Keywords: Fenugreek; Glucose Intolerance; Gymnema; Metabolic Disorder; Type 2 Diabetes Mellitus.

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