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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tabriz University of Medical Sciences

Criteria

Inclusion Criteria:

• At least 6 months of diagnosis of knee osteoarthritis, and whose OA diagnosis meets the American College of Rheumatology criteria,

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale baseline value of ≥ 9 (0-20 scale),

• Functional Capacity Classification of I-III,

• Radiograph evidence of OA in the target knee with a Kellgren-Lawrence score of 2 or 3,

• Morning stiffness of <30 min duration or crepitus on active motion, which are present upon examination.

Exclusion Criteria:

• Evidence of other conditions or diseases of the skin or joints,

• Evidence of partial or complete knee joint replacement or anticipated joint replacement in the target knee,

• Contraindications to the use of non-steroidal anti-inflammatory drugs (NSAIDs) or who use anticoagulant therapy that prohibits them from using NSAIDs,

• Pregnancy, planning to become pregnant or breastfeeding during the study period,

• Ischemic heart disease, heart failure, end-stage cirrhosis, end-stage renal failure, or psychiatric conditions that prevent an adequate evaluation of the study outcomes,

• Insufficient cognitive functioning to participate and complete the questionnaires,

• Unable or unwilling to follow up and complete the study pathway,

• Having active cancer undergoing treatment that prevents the evaluation of the outcome measures,

• A history or diagnosis of other arthritic conditions, such as rheumatoid arthritis, joint and bone deformities, fibromyalgia, and/or other inflammatory and immune system disorders,

• Type I or II diabetes or obesity (body mass index ≥ 39),

• Suffering from painful conditions or frequent headaches requiring the use of systemic opiates or derivatives, or the need for additional NSAID or COX-2 inhibitors,

• Receiving systemic or intra-articular corticosteroid injections.