Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-28 @ 10:28 AM
Study NCT ID:
NCT06912035
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Diacerein Supplementation on Interleukin-1β, Hs-CRP, TNF-α Levels and Glycemic Control in Uncontrolled Type 2 Diabetes Mellitus Patients at Dr. Mohammad Hoesin General Hospital Palembang
Sponsor:
Universitas Sriwijaya
Organization:
Study Overview
Official Title:
EFFICACY OF DIACEREIN ADDITION ON INTERLEUKIN-1Β, HS-CRP, TNF-Α LEVELS AND GLYCEMIC CONTROL IN UNCONTROLLED TYPE 2 DIABETES MELLITUS PATIENTS AT DR. MOHAMMAD HOESIN GENERAL HOSPITAL PALEMBANG
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if diacerein supplementation can help improve inflammation and glycemic control in adults with uncontrolled type 2 diabetes. It will also study the safety and tolerability of diacerein. The main questions it aims to answer are:
* Does diacerein lower levels of inflammatory markers like interleukin-1β, hs-CRP, and TNF-α?
* Does diacerein improve blood sugar control?
* What side effects or problems do participants have when taking diacerein?
Researchers will compare diacerein to a placebo (a look-alike substance with no active drug) to see if it works better for managing type 2 diabetes.
Participants will:
* Be adults aged 40-60 with uncontrolled type 2 diabetes
* Take either diacerein or a placebo every day for 12 weeks
* Visit the clinic for blood tests and monitoring at the beginning and end of the trial
* Be evaluated for side effects and medication adherence\]
* Does diacerein lower levels of inflammatory markers like interleukin-1β, hs-CRP, and TNF-α?
* Does diacerein improve blood sugar control?
* What side effects or problems do participants have when taking diacerein?
Researchers will compare diacerein to a placebo (a look-alike substance with no active drug) to see if it works better for managing type 2 diabetes.
Participants will:
* Be adults aged 40-60 with uncontrolled type 2 diabetes
* Take either diacerein or a placebo every day for 12 weeks
* Visit the clinic for blood tests and monitoring at the beginning and end of the trial
* Be evaluated for side effects and medication adherence\]
Detailed Description:
The study aimed to evaluate the efficacy of diacerein supplementation compared to placebo towards interleukin-1β, hs-CRP, TNF-α levels and glycemic control in uncontrolled type 2 diabetes mellitus patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited 40-60 years old with uncontrolled type 2 diabetes mellitus. Participants were randomized into two groups receiving diacerein add-on therapy or placebo. Evaluations were conducted for side effects and adherence. towards Interleukin-1β, hs-CRP, TNF-α levels and glycemic control were evaluated at the beginning and at the end of the 12 weeks trial for analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: