Efficacy and safety of Turmeric, Black Seeds, Flaxseed and Medicago Sativa in patients with osteoarthritis
- Conditions
- Knee osteoarthritis.Osteoarthritis of knee, unspecifiedM17.9
- Registration Number
- IRCT20220614055167N2
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
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 is present upon examination
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,
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.
Having active cancer undergoing treatment that prevents the evaluation of the outcome measures
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Joint pain. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.;Joint stiffness. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.;Physical function. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.;Overall Western Ontario and McMaster Universities Osteoarthritis score. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.;Subjective Global Evaluation (SGE). Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Subjective Global Evaluation forms.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Evaluation of patient’s quality of life, which will be measured using the 36-Item Short Form Survey which produces Mental Component and Physical Component scores.;Quality of sleep. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: The quality of sleep, which will be measured using the Pittsburgh Sleep Quality Index.;Functional Capacity Classification. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Functional Capacity Classification will be evaluated using a 4-point Likert scale and will be evaluated by the doctor and placed into 4 classes (Class I-IV), which range from full functional capacity to disabled.