| CTRI Number |
CTRI/2025/10/096385 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of colchicine in metabolic syndrome compared to placebo |
|
Scientific Title of Study
|
Efficacy and Safety of Colchicine compared to Placebo in Metabolic Syndrome Patients on Background Standard treatment. A Randomized, Double-Blind, Placebo- Controlled Prospective Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Poshala Srivarshini |
| Designation |
Junior Resident |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology,4 TH Floor, Administration Block,ESIC Medical College,Sanathnagar,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9494102526 |
| Fax |
|
| Email |
poshalasrivarshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Maleha Butul |
| Designation |
Associate professor |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology,4 TH Floor, Administration Block, ESIC MEDICAL College
,Sanathnagar,HYDERABAD
Hyderabad
TELANGANA
500038
India |
| Phone |
|
| Fax |
|
| Email |
butulmaleha67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Poshala Srivarshini |
| Designation |
Junior Resident |
| Affiliation |
ESIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Pharmacology,4 TH Floor,Administration Block,ESIC MEDICAL COLLEGE,Sanathnagar,HYDERABAD
Hyderabad
TELANGANA
500038
India |
| Phone |
9494102526 |
| Fax |
|
| Email |
poshalasrivarshini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrPoshala Srivarshini |
| Address |
4th floor, Department of pharmacology ESIC MEDICAL COLLEGE, Sanathnagar, Hyderabad 500038 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRPOSHALA SRIVARSHINI |
ESIC Medical college and Hospital |
Room no 4047,4th floor ,administration and academic block, ESIC Medical college ,hyderabad ,sanathnagar
Hyderabad
TELANGANA |
9494102526
poshalasrivarshini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE ESIC Medical College and Hospital and ESIC Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
colchicine |
0.5 mg once daily orally colchicine is given to metabolic syndrome patients in intervention group for 12 weeks |
| Comparator Agent |
placebo |
placebo is given for control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in mean hsCRP levels, waist circumference, TGA, HDL, weight, BP HOMA -IR |
from baseline to end of 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of adverse 1.drug reactions as proportions
2. Measurement of tolerability |
week 16 |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The trial is conducted by the department of pharmacology with endocrinology for the duration of 18 months. Participants will be explained about the procedures, treatment and side effect of interventional drug, in detail in the language best understood by them. After taking the informed consent, metabolic syndrome patients who meet inclusion criteria and willing to participate in study will be recruited. Subjects will be randomized into intervention and control groups based on computer generated randomization list. The control group will be given identical placebo and standard of care [stable oral dose of antihypertensives, anti-diabetics, statins and lifestyle modifications]. Intervention group will receive oral colchicine 0.5 mg once daily along with standard of care. Screening of participants for base line parameters [fasting insulin, lipid profile, fasting blood sugar, hsCRP, HbA1c, are done at -1 week [visit-1]. Participants are randomized to receive study medications at week 0 [visit -2]. hsCRP, abdominal circumference, weight, blood pressure recording and BMI will be done at week 4. All the base line parameters will be repeated at week 12. LFT and RFT will be done on week -1 and repeated on week 16. At week -1, 4, 12 and 16, about 10 ml of blood will be collected for study parameters. Participants will be given a diary to record any untoward event or any adverse drug reaction. Medication compliance will be checked by Pill count method. The effect of colchicine on inflammation markers, weight, abdominal circumference and BP will be recorded and HOMA-IR will be calculated. Participant complaints and clinical status will be assessed during each visit. If any side effects are reported, they will be advised to come to the study site for the management. The adverse effects will be reported to PVPI of india |