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OsteoarthritisPhase 2/3ETCSNCT07183215

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

A Phase 2/3 study testing Curcuminoid Standardized Turmeric Capsules in people with Osteoarthritis, run by Gadjah Mada University at 1 site in Indonesia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Curcuminoid Standardized Turmeric Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteIndonesia
Study dates
1 Jun 2025to 30 Oct 2025
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Parkinson's disease
  • Dementia disease
  • Psychosis disease
  • Fractures
  • Joint dislocations
  • Cancer
Show all 9Show fewer
  • Rheumatic diseases other than Osteoarthritis (rheumatoid arthritis)
  • Undergoing joint replacement therapy.
  • Analgesic dependent disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Indonesia1 site

  • GBI Ngadinegaran

    Yogyakarta, 64127

Other trials in Indonesia

About this study

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.
Read more

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
Read the 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
Being tested
Curcuminoid Standardized Turmeric Capsules, Placebo
Keywords
Osteoathritis, Pain, TNF Alfa, Interleukin 1, C-Reactive Protein
Medical subject headings
Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Curcuminoid Standardized Turmeric CapsulesDrug

    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

  • PlaceboOther

    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.

Study groups in NCT07183215
Study groupRoleWhat they receive
Intervention GroupExperimentalCapsules containing curcuminoid from Tumeric Extract three times a day for 3 weeks
Receives: Drug: Curcuminoid Standardized Turmeric Capsules
Control GroupPlacebo comparatorCapsules containing maltose three times a day for 3 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Secretion of TNF Alpha

    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

    Measured: 3 weeks

  2. Secretion of the Interleukin-1

    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

    Measured: 3 weeks

  3. Secretion of C Reactive Protein

    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.

    Measured: 3 weeks

Secondary outcomes (1)

  1. Change of Pain

    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.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start1 Jun 2025
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial, we will conduct a 2-arm, double-blind (patient and investigational blinded) to assess efficacy, tolerability and safety curcuminoid versus placebo.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07183215
Sponsor's protocol ID
055/20/VI/EC/KEPK/STIKES RSBK
Acronym
ETCS
Status last verified
Sep 2025
First submitted
6 Sep 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 38771152

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Curcuminoid Standardized Turmeric Capsules in people with Osteoarthritis, run by Gadjah Mada University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Secretion of TNF Alpha (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07183215, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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