A 90-day study to check how well GLUCETOL capsules work and how safe they are in people with type 2 diabetes, when used alone or along with other diabetes medicines.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Glucetol Capsule: Bhuiamla Extract (Phyllanthus amarus), Haldi Extract (Curcuma longa), Willow Bark Extract (Sali Xalba), Methi Extract (Trigonella foenum‐graecum), Tulsi Extract (Ocimum sanctum), Gudmar Extract (Gymnema slvystre), Karela Extract (Momordica charantia), Daruhaldi extract (Berberis aristata), Taurine, L‐Leucine 1 capsule thrice a day administered for 90 days with standard supportive care for diabetes. Control Intervention1: Placebo Capsule: 1 capsule thrice a day administered for 90 days with standard supportive care for diabetes. CONDITION: Health Condition 1: E119‐ Type 2 diabetes mellitus without complications PRIMARY OUTCOME: Absolute change in HbA1c (%) from baseline to Day 90 (primary analysis on mITT).Timepoint: Baseline to Day 90. SECONDARY OUTCOME: 1. Health‐Related Quality of Life (HRQoL) ‐ Diabetes Quality of Life Brief Clinical Inventory (DQoL‐BCI)scores from baseline to Day 90. ; 2. Glycemic control & insulin resistance: ; A. Change in fasting blood sugar (FBS) and post‐prandial blood sugar (PPBS) from baseline to Day 90. ; B. HbA1c responder rates: proportion achieving ; (i) HbA1c greater than 7.0 percent, and (ii) less than equal to 0.5 percent or less than equal to 1.0 percent absolute reduction at Day 90. ; C. Change in fasting insulin and HOMA‐IR from baseline to Day 90. ; 3. Cardiometabolic/inflammatory markers ; A. Change in lipid profile (total cholesterol, LDL‐C, HDL‐C, triglycerides) from baseline to Day 90. ; B. Change in C‐reactive protein (CRP) from baseline to Day 90.Timepoint: 1. HRQoL and DQoL‐BCI baseline to Day 90. ; 2. FBS, PPBS, insulin, and HOMA‐IR from baseline to Day 90. ; 3.1. Lipid profile (total cholesterol, LDL‐C, HDL‐C, triglycerides) from baseline to Day 90. ; 3.2. C‐reactive protein from baseline to Day 90. 4. Hepato‐renal / endocrine‐metabolic safety and status ; A. Liver function tests (ALT, AST); renal function (serum creatinine, eGFR) change ; baseline to Day 90. ; B. Electrolytes (Sodium ion, Potassium ion, Chloride ion, Bicarbonate (Hydrogen carbonate)); vitamin/mineral/endocrine status: Vitamin D3, Vitamin B12, total serum calcium, TSH‐change baseline to Day 90.Timepoint: 4. Liver function tests; renal function change baseline to Day 90. INCLUSION CRITERIA: 1. Age and Sex: Male or female adults aged 18 to 60 years at screening. 2. Confirmed Diagnosis of Type 2 Diabetes Mellitus (T2DM): Diagnosis established by ADA‐aligned criteria: a. FPG greater than or equal to 126 mg/dL. b. HbA1c greater than or equal to 6.5 percent. HbA1c Range ‐ 6.5 to 8.5 percent at screening. 3. Body Mass Inde X(BMI): 18.0 to 32.0 kg/m2. 4. Stable doses of chronic medications (antihypertensives, statins, thyroid replacement) for greater than or equal to 2 months. 5. Female Participants Women of childbearing potential must use effective mechanical contraception or maintain abstinence; Negative pregnancy test required (Pregnant or breastfeeding women excluded.) 6. Able to comprehend study requirements; provide written informed consent. 7. Willing to comply with visits, fasting assessments, lifestyle instructions, and investigational procedures for 90 days. <
Epistemonikos ID: abfb9f012159ab5365d002fc0a76ec0487cd9278
First added on: Jul 21, 2026