Abstract

INTEGRATIVE FORMULATION AND HUMAN TRIAL ASSESSMENT OF POLYHERBAL THERAPIES FOR SUSTAINED BLOOD GLUCOSE REGULATION IN DIABETIC PATIENTS

Abhilasha Gupta and Arun Sharma*

ABSTRACT

Type 2 diabetes mellitus (T2DM) is a Prolonged metabolic disease identified by consistently elevated glucose levels due to defective insulin action /or insufficient insulin production. While conventional pharmacological interventions are effective, they often entail side effects, resistance, and high treatment costs. In this context, polyherbal formulations rooted in traditional medicine offer a holistic, safe, and affordable alternative. The current study intended to establish and clinically assess a standardized herbal combination formulation comprising Aqueous-ethanolic extracts of Gymnema sylvestre, Momordica charantia, Trigonella foenum-graecum, and Syzygium cumini, selected for their well-documented antidiabetic properties. The formulation was optimized for synergistic efficacy and analyzed for bioactive compounds, confirming the detection of flavonoids, nitrogenous compounds such as alkaloids, saponins, and phenolics. Acute toxicity and stability assessments indicated safety and consistency of the product. A 12-week, open-label, prospective clinical trial was conducted on 60 T2DM patients (aged 35–65 years). Key outcome measures encompassed fasting glucose, postprandial glucose levels, and long-term glycemic marker HbA1c. The trial revealed statistically significant improvements: FBG declined from 162.3 mg/dL to 128.1 mg/dL, PPBG from 218.7 mg/dL to 171.5 mg/dL, and HbA1c from 8.1% to 6.9% (p < 0.01). No serious adverse effects were observed. Participants also reported improved energy, digestion, and sleep quality. These results suggest that the polyherbal formulation is effective and well-tolerated, offering a promising adjunct or alternative to standard diabetic care. Its multimechanistic action supports long-term glycemic control with minimal side effects. More comprehensive, controlled human trials are recommended to validate these results and establish broader clinical applicability.

Keywords: Polyherbal formulation; Type 2 Diabetes Mellitus (T2DM); Glycemic control; Phytochemical analysis; Clinical trial; Herbal medicine.