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Turmeric, Black Seeds, Flaxseed and Medicago Sativa in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:
The Joint Effects of Turmeric, Black Seeds, Flaxseed and Medicago Sativa for Relieving Symptoms of Knee Osteoarthritis: A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Clinical Trial Summary

This study investigates the safety and combined effect of Turmeric, Black Seeds, Flaxseed, and Medicago Sativa for relieving symptoms of knee osteoarthritis compared to the placebo group.

Clinical Trial Description

The present double-blind, randomized and placebo-controlled study will be conducted on patients with knee osteoarthritis to evaluate the safety and efficacy of a combined cream of Turmeric, Black Seeds, Flaxseed, and Medicago Sativa for relieving symptoms of knee osteoarthritis. The primary endpoints will be the pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) criteria, subject global evaluation (SGE), and the overall WOMAC score. Also, the secondary endpoints of this study include an evaluation of the quality of life, quality of sleep, and Functional Capacity Classification. A pilot study with 30 participants per arm will be conducted to estimate the final sample size. Adults over 40 years of age who have had OA for at least 6 months, and whose OA diagnosis meets the American College of Rheumatology criteria will be eligible to participate in the present study. Participants will be randomized in the intervention or placebo group to use a cream containing 95% vaseline and 5% mixed extract of Turmeric, Black Seeds, Flaxseed, and Medicago Sativa as intervention or cream of vaseline solely as a placebo. The cream will be administrated topically three times daily (9 AM, 3 PM, and 9 PM) for up to 12 weeks. The efficacy and safety of the creams will be measured during visits on days 30, 60, and 90 (final visit). Also, the complications and adherence of patients to intervention will be checked on days 15, 45, and 75 by telephonic discussion. The analysis will be performed based on the intent-to-treat method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05723458
Study type Interventional
Source Tabriz University of Medical Sciences
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date July 1, 2023
Completion date September 1, 2024
View Details
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