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

NCT05723458 | Unknown Phase 1

• 1 other identifier: 70180
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Turmeric; Black Seeds; Flaxseed; Medicago Sativa

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Quality of life index

  Day 0, 30, 60, 90 post intervention

• Pittsburgh Sleep Quality Index score

  Day 0, 30, 60, 90 post intervention

• Functional Capacity Classification

  Day 0, 30, 60, 90 post intervention

Study Arms (2)

Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa

ACTIVE COMPARATOR

Combination Product: Cream

Placebo cream containing vaseline

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cream COMBINATION_PRODUCT

A cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa

Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa

Placebo DRUG

Placebo cream containing vaseline

Placebo cream containing vaseline

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

Study Sites (1)

Imam Reza hospital and clinic of Salamat

Tabriz, AzarbayejaneShargi, 5166614766, Iran

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 10, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)