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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Combination Product: Cream
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa<br> | Combination Product: Cream<br>* A cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa<br>|
| Placebo Comparator: Placebo cream containing vaseline<br> | Drug: Placebo<br>* Placebo cream containing vaseline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria | Change in pain subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria in response to intervention. The pain subscale scores range from 0 (no pain with all 5 activities, ie, flat surface walking, stairclimbing, at night, sitting or lying, standing) to 20 (extreme pain with all 5 activities). Higher scores represent worse situation. | Day 0, 30, 60, 90 post intervention | 
| Stiffness subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria | Change in stiffness subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria in response to intervention. The scores for stiffness subscale range from 0 to 8 and higher scores represent worse situation. | Day 0, 30, 60, 90 post intervention | 
| Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria | Change in physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria in response to intervention. The scores for physical function subscale range from 0 to 68 and higher scores represent more physical limitation. | Day 0, 30, 60, 90 post intervention | 
| Overall Western Ontario and McMaster Universities Osteoarthritis score | Change in overall Western Ontario and McMaster Universities Osteoarthritis score in response to intervention. The scores for each subscale are summed up, with a possible score range of 0-96 and higher scores indicate worse pain, stiffness, and functional limitations. | Day 0, 30, 60, 90 post intervention | 
| Subjective Global Evaluation | Change in Subjective Global Evaluation in response to intervention. According to the Subjective Global Evaluation questionnaire, the status of the patients is determined as normal (0), mild (1+), moderate (2+) or severe (3+) malnutrition. | Day 0, 30, 60, 90 post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life index | Change in quality of life index in response to intervention | Day 0, 30, 60, 90 post intervention | 
| Pittsburgh Sleep Quality Index score | Change in the Pittsburgh Sleep Quality Index score in response to intervention. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality. | Day 0, 30, 60, 90 post intervention | 
| Functional Capacity Classification | Change in Functional Capacity Classification in response to intervention. It is measured in a 4 point Likert scale and higher values represent worse situation. | Day 0, 30, 60, 90 post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, Turmeric, Black Seeds, Flaxseed, Medicago Sativa