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.

A Multicenter, Randomized, Double Blind, Placebo Controlled, 90 Day, Four Arm, Parallel Group Study to Evaluate the Efficacy and Safety of GLUCETOL as a Add On to Stable Oral Hypoglycemic Agents and as a Monotherapy in Newly Diagnosed, Drug Na ve Type 2 Diabetes, on HbA1c levels over 90 Days.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/107176

Enrollment

200

Registered

2026-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Glucetol Capsule: Bhuiamla Extract (Phyllanthus amarus), Haldi Extract (Curcuma longa), Willow Bark Extract (Salix alba), Methi Extract (Trigonella foenum-graecum), Tulsi Extract (Ocimu

Eligibility

Inclusion criteria

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 Index (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. Cohort-Specific Inclusion Criteria Cohort A 1. On metformin greater than or equal to 1000 mg/day (IR or ER) for greater than or equal to 12 weeks; and/or Second Oral Hypoglycemic Agent (exactly one) One of Sulfonylurea (e.g., glimepiride less than or equal to 4 mg/day or equivalent); DPP 4 inhibitor; SGLT 2 inhibitor; Stable dose, frequency, and class for greater than or equal to 12 weeks. 2. No addition, discontinuation, or dose adjustments of OHAs within 12 weeks prior to screening. Cohort B 1. Newly Diagnosed / Drug Na ve T2DM (n 100); (Aligned with VERIFY and GRADE baseline definitions); Drug-Na ve Glycemic Status No use of any glucose-lowering medication in the previous 12 weeks. 2. Newly diagnosed T2DM or previously diagnosed but untreated.

Exclusion criteria

Exclusion criteria: 1. Type 1 Diabetes Mellitus: History of type 1 diabetes or diabetic ketoacidosis. 2. Severe Hyperglycemia: HbA1c greater than 8.5 percent at screening. 3. Uncontrolled Lipid Abnormalities: TG greater 500 mg/dL or LDL-C greater than 200 mg/dL. 4. Major Systemic Diseases i.e. Active malignancy, Renal impairment: eGFR less than 30 mL/min/1.73 m2, Hepatic disease: AST/ALT less than 5 ULN, Cardiovascular events (MI, stroke) within the past 6 months. 5. Prohibited Medication Use: Insulin, GLP-1 RA, TZDs, or greater than 2 OHAs; Systemic corticosteroids; Immunosuppressants; Ayurvedic/homeopathic/herbal anti-diabetic agents in the past 30 days. 6. Active or Chronic Infections; TB, HBV, HCV, HIV, or infections requiring ongoing therapy. 7. Hypersensitivity: Allergy to investigational products or excipients. 8. Psychiatric or Cognitive Disorders: Schizophrenia, bipolar disorder, severe depression, or cognitive impairment affecting adherence. 9. Substance Abuse: Alcohol or illicit drug abuse within the last 6 months. 10. Gastrointestinal Disorders: Gastroparesis, malabsorption, IBD, bowel resection, or conditions altering drug absorption. 11. Bleeding or Hematological Disorders: Hemophilia, von Willebrand disease, or high-risk anticoagulation. 12. Electrolyte Disturbances: Clinically significant abnormalities impacting safety or glycemic outcomes. 13. Recent Clinical Trial Participation: Participation in another investigational study within the past 3 months. 14. Other Investigator-Determined Risk: Any medical, psychological, or logistical factor that may increase risk, confound results, or interfere with protocol compliance.

Design outcomes

Primary

Measure	Time frame
Absolute change in HbA1c (%) from baseline to Day 90 (primary analysis on mITT).Timepoint: Baseline to Day 90.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

India

Contacts

Public ContactDurvesh Sawant

Integrity Healthcare Services

amaurya@ihsindia.com9821471425

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026