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

NCT07183215 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: 055/20/VI/EC/KEPK/STIKES RSBK
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Osteoarthritis

Keywords

Osteoathritis; Pain; TNF Alfa; Interleukin 1; C-Reactive Protein

Outcome Measures

Primary Outcomes (3)

• 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

  3 weeks

• 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

  3 weeks

• 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.

  3 weeks

Secondary Outcomes (1)

• Change of Pain

  3 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Drug: Curcuminoid Standardized Turmeric Capsules

Control Group

PLACEBO COMPARATOR

Capsules containing maltose three times a day for 3 weeks

Other: Placebo

Interventions

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

Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

GBI Ngadinegaran

Yogyakarta, 64127, Indonesia

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

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

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 19, 2025
• Study Start: June 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)