Efficacy Test of Curcuminoid Standardized Turmeric Capsules to Improving Inflammatory Biomarkers in Osteoarthritis Genu
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Curcuminoid Standardized Turmeric Capsules, Placebo.
- Who it may be relevant to
- Registry conditions: Osteoarthritis. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- 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.
Primary outcome measures
- Secretion of TNF Alpha [Time frame: 3 weeks]
- Secretion of the Interleukin-1 [Time frame: 3 weeks]
- Secretion of C Reactive Protein [Time frame: 3 weeks]
Secondary outcome measures (1)
- Change of Pain [Time frame: 3 weeks]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of Osteoarthritis which confirmed by physical examination and x-rays
- Experience pain with a Numeric Rating scale of 1-7
- Must be able to swallow capsules
- Must be able to carry out mobility without assistance or with minimal assistance
Exclusion criteria
- Parkinson's disease
- Dementia disease
- Psychosis disease
- Fractures
- Joint dislocations
- Cancer
- Rheumatic diseases other than Osteoarthritis (rheumatoid arthritis)
- Undergoing joint replacement therapy.
- Analgesic dependent disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- GBI Ngadinegaran — Yogyakarta
Publications
- Koroljevic ZD, Jordan K, Ivkovic J, Bender DV, Peric P. Curcuma as an anti-inflammatory component in treating osteoarthritis. Rheumatol Int. 2023 Apr;43(4):589-616. doi: 10.1007/s00296-022-05244-8. Epub 2022 Nov 17. PMID 36394597
- Mahanani S, Kertia N, Madyaningrum E. Combination of Curcuminoids and Acupressure for Inflammation and Pain in Older People with Osteoarthritis Genu: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 24;13:e54970. doi: 10.2196/54970. PMID 38771152
Identifiers
NCT: NCT07183215 · 055/20/VI/EC/KEPK/STIKES RSBK