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

Gadjah Mada University

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Osteoarthritis

Treatments: Other: Placebo; Drug: Curcuminoid Standardized Turmeric Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT07183215

055/20/VI/EC/KEPK/STIKES RSBK

Details and patient eligibility

About

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

Full 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

Enrollment: 72 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of Osteoarthritis which confirmed by physical examination and x-rays
2. Experience pain with a Numeric Rating scale of 1-7
3. Must be able to swallow capsules
4. Must be able to carry out mobility without assistance or with minimal assistance

Exclusion criteria

1. Parkinson's disease
2. Dementia disease
3. Psychosis disease
4. Fractures
5. Joint dislocations
6. Cancer
7. Rheumatic diseases other than Osteoarthritis (rheumatoid arthritis)
8. Undergoing joint replacement therapy.
9. Analgesic dependent disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

Capsules containing curcuminoid from Tumeric Extract three times a day for 3 weeks

Treatment:

Drug: Curcuminoid Standardized Turmeric Capsules

Control Group

Placebo Comparator group

Description:

Capsules containing maltose three times a day for 3 weeks

Treatment:

Other: Placebo