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Effect of colchicine in metabolic syndrome compared to placebo

Efficacy and Safety of Colchicine compared to Placebo in Metabolic Syndrome Patients on Background Standard treatment. A Randomized, Double-Blind, Placebo- Controlled Prospective Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096385
Enrollment
84
Registered
2025-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: E889- Metabolic disorder, unspecified

Interventions

Intervention1: colchicine: 0.5 mg once daily orally colchicine is given to metabolic syndrome patients in intervention group for 12 weeks Control Intervention1: colchicine vs placebo: In one group of

Sponsors

DrPoshala Srivarshini
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1]BMI greater than or equal to 30mg/dl. 2]Impaired glucose tolerance less than 200mg/dl and greater than 140 mg/dl at 2hrs of OGTT and FBS is greater than 100 and less than 126 mg/dl. 3]All patients having fasting blood sugars greater than or equal to 126mg/dl and post prandial greater than 140 mg/dl after 120 minutes and HbA1c greater than or equal to 5.7% and less than or equal to 10% 4]HTN greater than or equal to 130 mm of Hg systolic pressure and greater than equal to 85mm of Hg diastolic pressure 5]Waist circumference greater than 102cm in Men and 88 cm in women 5]triglycerides greater than or equal to 150 to 250 mg/dl and HDL less than 40 mg/dl

Exclusion criteria

Exclusion criteria: Exclusion Criteria: a. History of hypersensitivity to colchicine b. Participants on myoinositol in metabolic syndrome, aspirin, NSAIDS, corticosteroids c. liver function tests Parameter Normal Range (Male) Normal Range (Female) Alanine aminotransferase 10–55 U/L 7–30 U/L Aspartate aminotransferase 10–40 U/L 9–25 U/L Alkaline Phosphatase 45–115 U/L 30–100 U/L Total Bilirubin 0–1.0 mg/dL 0–1.0 mg/dL 0–0.4 mg/dL Direct Bilirubin 0–0.4 mg/dL Prothrombin Time 11.2–13.2 seconds 11.2–13.2 seconds greater than 3 times of Upper limit value (8) 4. Renal function tests Parameter Normal Range Serum Creatinine 0.6–1.2 mg/dL Blood Urea Nitrogen (BUN) 7–20 mg/dL (8) greater than 3 times of Upper limit value 5. Pregnancy and Lactating mothers 6. On weight loss program

Design outcomes

Primary

MeasureTime frame
Percentage change in mean hsCRP levels, waist circumference, TGA, HDL, weight, BP HOMA -IRTimepoint: from baseline to end of 12 weeks.—

Secondary

MeasureTime frame
1. Incidence of adverse 1.drug reactions as proportions 2. Measurement of tolerabilityTimepoint: week 16—

Countries

India

Contacts

Public ContactDR Poshala Srivarshini

ESIC MEDICAL COLLEGE AND HOSPITAL

butulmaleha67@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026