Knee OsteoarthritisPhase 1/2NCT05723458
Turmeric, Black Seeds, Flaxseed and Medicago Sativa in Knee Osteoarthritis
A Phase 1/2 study testing Cream in people with Knee Osteoarthritis, run by Tabriz University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2023to 1 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Imam Reza hospital and clinic of Salamat
Tabriz, AzarbayejaneShargi, 5166614766
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Cream, Placebo
- Keywords
- Knee osteoarthritis, Turmeric, Black Seeds, Flaxseed, Medicago Sativa
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreamCombination product
A cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa
PlaceboDrug
Placebo cream containing vaseline
| Study group | Role | What they receive |
|---|---|---|
| Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa | Active comparator | Not described Receives: Combination Product: Cream |
| Placebo cream containing vaseline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, 30, 60, 90 post intervention
Secondary outcomes (3)
Quality of life index
Change in quality of life index in response to intervention
Measured: 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.
Measured: 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.
Measured: Day 0, 30, 60, 90 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabriz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Saeid Safiri, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723458
- Sponsor's protocol ID
- 70180
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05723458
- Acronym / sponsor ID
- 70180
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Turmeric, Black Seeds, Flaxseed, Medicago Sativa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tabriz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa | Active comparator | Combination Product: Cream |
| Placebo cream containing vaseline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreamA cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa | Combination product | Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa |
| PlaceboPlacebo cream containing vaseline | Drug | Placebo cream containing vaseline |
Primary outcome
Pain subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria
Time frame: Day 0, 30, 60, 90 post intervention
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
Time frame: Day 0, 30, 60, 90 post intervention
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
Time frame: Day 0, 30, 60, 90 post intervention
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
Time frame: Day 0, 30, 60, 90 post intervention
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
Time frame: Day 0, 30, 60, 90 post intervention
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.
3 secondary outcomes
Quality of life index
Time frame: Day 0, 30, 60, 90 post intervention
Pittsburgh Sleep Quality Index score
Time frame: Day 0, 30, 60, 90 post intervention
Functional Capacity Classification
Time frame: Day 0, 30, 60, 90 post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cream in people with Knee Osteoarthritis, run by Tabriz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain subscale of the Western Ontario and McMaster Universities Osteoarthritis criteria (time frame: Day 0, 30, 60, 90 post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.