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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Combination product: Cream; Drug: Placebo

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • AzarbayejaneShargi
    • Tabriz, AzarbayejaneShargi, Iran, Islamic Republic of, 5166614766
      • Imam Reza hospital and clinic of Salamat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa	Combination product: Cream; A cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa
Placebo Comparator: Placebo cream containing vaseline	Drug: Placebo; Placebo cream containing vaseline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tabriz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Knee osteoarthritis; Turmeric; Flaxseed; Black Seeds; Medicago Sativa
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 70180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No