NCT06912035

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

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Universitas Sriwijaya · Academic / Other
• Sex: All
• Age: 60 Years – 60 Years
• Healthy volunteers: Not accepted

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\]

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.

Conditions

• Uncontrolled Diabetes
• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DRUG	Diacerein 50 mg Capsule	The patients received diacerein capsules
DRUG	Placebo	Patients received placebo capsules

Timeline

• Start date: 2024-06-21
• Primary completion: 2024-11-08
• Completion: 2024-11-08
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: Indonesia