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

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cream
Placebo
Sponsored by
Tabriz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Turmeric, Black Seeds, Flaxseed, Medicago Sativa

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imam Reza hospital and clinic of Salamat

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

Placebo cream containing vaseline

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Quality of life index
Change in quality of life index in response to 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.
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.

Full Information

First Posted
January 17, 2023
Last Updated
April 11, 2023
Sponsor
Tabriz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05723458
Brief Title
Turmeric, Black Seeds, Flaxseed and Medicago Sativa in Knee Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tabriz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Turmeric, Black Seeds, Flaxseed, Medicago Sativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa
Arm Type
Active Comparator
Arm Title
Placebo cream containing vaseline
Arm Type
Placebo Comparator
Intervention Type
Combination Product
Intervention Name(s)
Cream
Intervention Description
A cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo cream containing vaseline
Primary Outcome Measure Information:
Title
Pain subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria
Description
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.
Time Frame
Day 0, 30, 60, 90 post intervention
Title
Stiffness subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria
Description
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.
Time Frame
Day 0, 30, 60, 90 post intervention
Title
Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria
Description
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.
Time Frame
Day 0, 30, 60, 90 post intervention
Title
Overall Western Ontario and McMaster Universities Osteoarthritis score
Description
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.
Time Frame
Day 0, 30, 60, 90 post intervention
Title
Subjective Global Evaluation
Description
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.
Time Frame
Day 0, 30, 60, 90 post intervention
Secondary Outcome Measure Information:
Title
Quality of life index
Description
Change in quality of life index in response to intervention
Time Frame
Day 0, 30, 60, 90 post intervention
Title
Pittsburgh Sleep Quality Index score
Description
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.
Time Frame
Day 0, 30, 60, 90 post intervention
Title
Functional Capacity Classification
Description
Change in Functional Capacity Classification in response to intervention. It is measured in a 4 point Likert scale and higher values represent worse situation.
Time Frame
Day 0, 30, 60, 90 post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Imam Reza hospital and clinic of Salamat
City
Tabriz
State/Province
AzarbayejaneShargi
ZIP/Postal Code
5166614766
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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