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Enrolling by Invitation

NCT Number: NCT07183215

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

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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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

GBI Ngadinegaran

Yogyakarta, 64127, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcuminoid Standardized Turmeric Capsules

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

Placebo

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.

Primary outcomes

  1. Secretion of TNF Alpha

    Time frame: 3 weeks

    TNF alpha is a cytokine, a protein that plays a role in the immune system and inflammation. TNF alpha is produced by various types of cells, particularly activated macrophages, and plays a role in various biological processes such as inflammation and immunity against infection.

    The cytokine TNF alpha is an essential mediator in increasing the inflammatory response, which can be detected in the blood plasma of patients with Osteoarthritis. The TNF alpha examination was conducted using the Enzyme Linked Immunosorbent Assay (ELISA) method on blood plasma

  2. Secretion of the Interleukin-1

    Time frame: 3 weeks

    Interleukin-1 is a pro-inflammatory cytokine that plays a key role in immune and inflammatory responses, produced primarily by macrophages. IL-1 can cause fever, increase blood vessel permeability, and trigger bone and cartilage damage.

    The cytokine Interleukin-1 is an essential mediator in increasing the inflammatory response, which can be detected in the blood plasma of patients with Osteoarthritis. The Interleukin-1 examination was conducted using the Enzyme Linked Immunosorbent Assay (ELISA) method on blood plasma

  3. Secretion of C Reactive Protein

    Time frame: 3 weeks

    C-reactive protein (CRP) is a blood marker for inflammation in the body, produced by the liver in response to infection, injury, or autoimmune conditions. A simple blood test measures CRP levels, with higher concentrations indicating greater inflammation.

    C-reactive protein (CRP) is measured with a blood test to detect and monitor inflammation in your body. A blood sample is taken from a vein and analyzed in a laboratory to determine the CRP level. The results are reported in milligrams per liter (mg/L), and higher than normal levels indicate inflammation that may be caused by infection, injury, or a chronic condition.

Secondary outcomes

  1. Change of Pain

    Time frame: 3 weeks

    Therapy effectiveness is the ability of a given treatment regimen to suppress several expected outcome indicators. Other outcome indicators were measured before starting therapy and after 3 weeks of therapy, including knee pain, as measured using a VAS score. Pain is expressed on a scale of 0 to 10, with higher numbers indicating more severe pain.

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Acronym: ETCS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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