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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-10-30

Brief Summary

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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

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Detailed Description

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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

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, we will conduct a 2-arm, double-blind (patient and investigational blinded) to assess efficacy, tolerability and safety curcuminoid versus placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Curcuminoid Standardized Turmeric Capsules

Intervention Type DRUG

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

Control Group

Capsules containing maltose three times a day for 3 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No