NCT07183215

Efficacy Test of Curcuminoid Standardized Turmeric Capsules to Improving Inflammatory Biomarkers in Osteoarthritis Genu

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Gadjah Mada University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Curcuminoid Standardized Turmeric Capsules works to treat Osteoarthritis Genu in adults. It will also learn about the safety of Curcuminoid Standardized Turmeric Capsules. The main questions it aims to answer are: * Does Curcuminoid Standardized Turmeric Capsules lower the pain, TNF-Alpha, Interleukin-1 and CRP in the blood? * What medical problems do participants have when taking Curcuminoid Standardized Turmeric Capsules? Researchers will compare Curcuminoid Standardized Turmeric Capsules to a placebo to see if Curcuminoid Standardized Turmeric Capsules works to treat Osteoarthritis Genu. Participants will: * Take Curcuminoid Standardized Turmeric Capsules or a placebo every day for 3 weeks * Visit the clinic once every week for checkups and tests * Keep a diary of their symptoms and the number of times they use a rescue paracetamol

Detailed description

Evaluate the efficacy, safety, and tolerability of standardized curcuminoid from turmeric extract to TNF-Alpha, Interleukin-1 and CRP in elderly patients with Osteoarthritis Genu. This research is also to evaluate the effect of acupressure and standardized curcuminoid from turmeric extract vs placebo at three weeks : Knee pain as measured by the VAS score. Study design is randomized controlled trial, double-blind to assess efficacy, tolerability, and safety curcuminoid versus placebo. Patients can be pre-screened for specific x-ray and laboratory parameters. Eligible subjects will enter the washout for one week following a screening visit. After the washout period, eligible subjects will be randomized and treated for three weeks. The total duration of the study is up to 5 weeks. The primary efficacy variable is the number of TNF-Alpha, Interleukin-1 and CRP in blood, collected at Week 4 to BL (i.e., change from BL in the number of Leukocytes at Week 4). It will be analyzed using the Wilcoxon signed-rank test or paired t-test and the Mann-Whitney U test or independent t-test. The significance level will be set at 0.05. All outcome measures will be recorded at baseline and after two weeks of intervention

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Curcuminoid Standardized Turmeric Capsules	Samples were made from extracted turmeric and then optimized. The capsule formulation is made from turmeric rhizome extract which contains 30 mg of curcuminoids per capsule. In the study, standardized curcuminoid turmeric extract was given in capsules at 30 mg 3 times a day for 3 weeks
OTHER	Placebo	The capsule formulation is made from maltose which contains 10 mg of curcuminoids per capsule. In the study, the capsule was given in capsules at 30 mg 3 times a day for 3 weeks.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-09-30
• Completion: 2025-10-30
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: Indonesia