Osteo Arthritis KneeNCT06029868
Black Seed Oil in Treatment of Osteoarthritis
A study testing Black seed oil capsule in people with Osteo Arthritis Knee, run by Ramsar international campus at 1 site in Iran.
Trial summary
Osteoarthritis is a continual illness of joints. We aim to investigate the effect of Nigella sativa oil in comparison with placebo on the reduction of osteoarthritis pain. This study is a double-blinded, randomized, controlled trial study, conducting in Vali-e-Asr Hospital in 2019, in Birjand, on patients with mild… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Black seed oil capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIran
- Study dates
- 14 Jan 2019to 12 Feb 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral or bilateral involvement of one or more joints for over 4 months,
- ability to walk
- ability to stay throughout the study period
- no history of underlying inflammatory disease (arthropathy / rheumatoid arthritis),
- absence of diabetes,
- no history of allergy to black seed
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- absence of hyperuricemia (<338 umol/l) or history of gout,
- absence of recent injury and trauma to the joint with osteoarthritis,
- absence of intra articular injection of corticosteroids in the last 4 months,
- lack of sensitivity to NSAIDS,
- no underlying liver and kidney disease or history of peptic ulcer Or gastrointestinal bleeding, Congestive Heart Failure, hypertension, and hyperkalemia ,
- no fever
- absence of obvious Complete Blood Count disorders, coagulopathy, hematologic or neurological disorders ,
- no alcohol consumption
Who cannot join
- pregnancy,
- breast feeding,
- pregnancy-related decision
- obesity (BMI> 30 kg /m2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Process of Dryness, Limited Movement, and Joint Pain Using the Black Seed in Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Osteoarthritis is a continual illness of joints. We aim to investigate the effect of Nigella sativa oil in comparison with placebo on the reduction of osteoarthritis pain.
This study is a double-blinded, randomized, controlled trial study, conducting in Vali-e-Asr Hospital in 2019, in Birjand, on patients with mild osteoarthritis. The Western Ontario and McMaster Universities Osteoarthritis Index is applied to score the functional status of participants' joints.
Read the detailed description
This study was a randomized controlled trial. Regarding to the inclusion criteria, 110 osteoarthritis patients were included in this study based on clinical signs, physical examination and radiological signs. In the next step, a fully explanation was given to the participants around the conditions of conducting the research, and then the informed consent were collected. Subsequently, patients were randomly divided into two groups of recipients; black seed soft gel capsules (intervention) and placebo equally in accordance with demographic information. Furthermore, the two groups were randomly classified regarding to age, consequently the study population was divided into subgroups of categorized ages. Thereafter, an equal number of each subgroup was randomly selected and divided into two groups to take black seed and placebo. Therefore, the two groups were similar, but the exact membership of individuals in the groups were random. Due to the higher prevalence of osteoarthritis among women in the community, the number of female cases were higher. It should be noted that the experimenters as well as patients did not know who was receiving a particular treatment (Double-blinded study). Prior to commencing the study, participants were asked to take a regular 48-day course of anti-inflammatory therapy. The cases in the intervention group took 700 mg of black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company, and the control group were treated by placebo capsules in the same-color and shape of the drug, with a taste of rice bran. Moreover, questionnaires were filled to record demographic information of both groups including age, sex, history medication and diet. The condition of participants were evaluated twice before the treatment and 48 days after the onset of black seed. At the end of each period, joint pain scores, the range of activity, and the dryness of the joints of all patients were assessed, and their mean were measured.
Data collection tools:
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[2]. The WOMAC questionnaire was published in the 1908s to assess osteoarthritis of hip and knee, which is a standard criterion for assessing the health status of patients' self-reported activity. Three criteria should be measured ranging between zero to 4 for each question, by the end of each evaluation period: reduce pain is identified based on the mean for the first 5 WOMAC questions (from no pain to severe pain), the 6th and 7th questions were specified for joint dryness (from no dryness to severe limitation),and Joint movement is determined based on the average of questions 0 to 24 (from no problem to severe limit).
- Conditions
- Osteo Arthritis Knee
- Being tested
- Black seed oil capsule, Placebo Black seed oil capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black seed oil capsuleDietary supplement
700 mg black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company,
Placebo Black seed oil capsuleDietary supplement
Placebo Black seed oil capsule
| Study group | Role | What they receive |
|---|---|---|
| Black seed | Experimental | Black seed oil capsule taken orally Receives: Dietary Supplement: Black seed oil capsule |
| Placebo | Placebo comparator | Placebo capsule taken orally Receives: Dietary Supplement: Placebo Black seed oil capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint pain
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) .reduce pain is identified based on the mean for the first 5 WOMAC questions (from no pain to severe pain)
Measured: 48 days
joint movement limitation
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Joint movement is determined based on the average of questions 0 to 24 (from no problem to severe limit).
Measured: 48 days
joint dryness
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). the 6th and 7th questions were specified for joint dryness (from no dryness to severe limitation)
Measured: 48 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start14 Jan 2019
- Primary completion20 Jun 2019
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramsar international campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Khodashenas Roudsari, Ramsar international campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029868
- Sponsor's protocol ID
- IR.BUMS. REC.1398.020
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Process of Dryness, Limited Movement, and Joint Pain Using the Black Seed in Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06029868
- Acronym / sponsor ID
- IR.BUMS. REC.1398.020
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ramsar international campusUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 8 Sep 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.
Osteoarthritis is a continual illness of joints. We aim to investigate the effect of Nigella sativa oil in comparison with placebo on the reduction of osteoarthritis pain.
This study is a double-blinded, randomized, controlled trial study, conducting in Vali-e-Asr Hospital in 2019, in Birjand, on patients with mild osteoarthritis. The Western Ontario and McMaster Universities Osteoarthritis Index is applied to score the functional status of participants' joints.
Detailed description
This study was a randomized controlled trial. Regarding to the inclusion criteria, 110 osteoarthritis patients were included in this study based on clinical signs, physical examination and radiological signs. In the next step, a fully explanation was given to the participants around the conditions of conducting the research, and then the informed consent were collected. Subsequently, patients were randomly divided into two groups of recipients; black seed soft gel capsules (intervention) and placebo equally in accordance with demographic information. Furthermore, the two groups were randomly classified regarding to age, consequently the study population was divided into subgroups of categorized ages. Thereafter, an equal number of each subgroup was randomly selected and divided into two groups to take black seed and placebo. Therefore, the two groups were similar, but the exact membership of individuals in the groups were random. Due to the higher prevalence of osteoarthritis among women in the community, the number of female cases were higher. It should be noted that the experimenters as well as patients did not know who was receiving a particular treatment (Double-blinded study). Prior to commencing the study, participants were asked to take a regular 48-day course of anti-inflammatory therapy. The cases in the intervention group took 700 mg of black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company, and the control group were treated by placebo capsules in the same-color and shape of the drug, with a taste of rice bran. Moreover, questionnaires were filled to record demographic information of both groups including age, sex, history medication and diet. The condition of participants were evaluated twice before the treatment and 48 days after the onset of black seed. At the end of each period, joint pain scores, the range of activity, and the dryness of the joints of all patients were assessed, and their mean were measured.
Data collection tools:
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[2]. The WOMAC questionnaire was published in the 1908s to assess osteoarthritis of hip and knee, which is a standard criterion for assessing the health status of patients' self-reported activity. Three criteria should be measured ranging between zero to 4 for each question, by the end of each evaluation period: reduce pain is identified based on the mean for the first 5 WOMAC questions (from no pain to severe pain), the 6th and 7th questions were specified for joint dryness (from no dryness to severe limitation),and Joint movement is determined based on the average of questions 0 to 24 (from no problem to severe limit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black seed | Experimental | Dietary Supplement: Black seed oil capsuleBlack seed oil capsule taken orally |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Black seed oil capsulePlacebo capsule taken orally |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- unilateral or bilateral involvement of one or more joints for over 4 months,
- ability to walk
- ability to stay throughout the study period
- no history of underlying inflammatory disease (arthropathy / rheumatoid arthritis),
- absence of diabetes,
Key exclusion criteria (4 listed)
- pregnancy,
- breast feeding,
- pregnancy-related decision
- obesity (BMI> 30 kg /m2).
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 |
|---|---|---|
| Black seed oil capsule700 mg black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company, | Dietary supplement | Black seed |
| Placebo Black seed oil capsulePlacebo Black seed oil capsule | Dietary supplement | Placebo |
Primary outcome
Knee joint pain
Time frame: 48 days
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) .reduce pain is identified based on the mean for the first 5 WOMAC questions (from no pain to severe pain)
joint movement limitation
Time frame: 48 days
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Joint movement is determined based on the average of questions 0 to 24 (from no problem to severe limit).
joint dryness
Time frame: 48 days
Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). the 6th and 7th questions were specified for joint dryness (from no dryness to severe limitation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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 study testing Black seed oil capsule in people with Osteo Arthritis Knee, run by Ramsar international campus 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 14 inclusion and 4 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: finished, as of the sponsor's last update on 8 Sep 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee joint pain (time frame: 48 days). The study lists 3 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 8 Sep 2023.