OsteoarthritisPhase 3NCT03715140
Crucumin Effects on the Immune System in Osteoarthritis Patients
A Phase 3 study testing Crucumin in people with Osteoarthritis, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
In this study, the effects of crucumin on cellular and humoral immune system in patients with osteoarthritis will be investigated. Concentration of CXCL8, April, CX3CL1 and IL-17 will be evaluated with ELISA. TH-1, TH-17, TReg and Ly.B cells count will be measured by Flowcytometry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Crucumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 May 2019to 30 Dec 2020
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Osteoarthritis patients who have been diagnosed with a rheumatologist physician based on clinical examinations and laboratory tests
Who cannot join
- Affected by any other acute or chronic underlying disease
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mahdi Atabaki
Mashhad, 9188815435
Mahdi Atabaki, Ph.D Candidate, +989303043900, atabaki80@gmail.com
About this study
Official title: Evaluation of the Crucumin Effects on the Cellular and Humoral Immune Systems in Osteoarthritis Patients; a Randomised Double Blind Placebo Control Clinical Trial
In this study, the effects of crucumin on cellular and humoral immune system in patients with osteoarthritis will be investigated. Concentration of CXCL8, April, CX3CL1 and IL-17 will be evaluated with ELISA. TH-1, TH-17, TReg and Ly.B cells count will be measured by Flowcytometry. MicroRNA-720, MicroRNA-155, MicroRNA-16 and MicroRNA-146a gene expression will be measured with Real Time PCR technique.
Read the detailed description
The purpose of this study was to evaluate the effect of the active ingredient of crucumin on the reduction of symptoms of osteoarthritis. Of the 30 patients participating in this study, a blood sample will be taken at the beginning of the study, and then after three months of taking the crucumin. To evaluate the response to treatment, after each person sampling, we will analyze cell count for Th-1, Th-17, TReg and Ly.B by flowcytomtry method. Also we will measure cytokines level of IL-17, CXCL8, CX3CL1 and April by ELISA method. Finally we evaluate the gene expression of MicroRNA-720, MicroRNA-155, MicroRNA-146a and MicroRNA-16 by Real Time PCR technique.
- Conditions
- Osteoarthritis
- Being tested
- Crucumin, Placebo
- Keywords
- Osteoarthritis, Crucumin, Flowcytometry
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrucuminDrug
Also called nanocrucumin
Evaluation of the effect of Crucumin in patients with osteoarthritis
PlaceboDrug
Also called Crucumin placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Patients who will recieve crucumin | Experimental | patients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug. Receives: Drug: Crucumin |
| Patients who will receive placebo | Placebo comparator | Patients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-17
Cytokine level
Measured: Baseline
Secondary outcomes (12)
IL-17
Cytokine level
Measured: Baseline and three months
TH-1
Cell counting
Measured: Baseline and three months
MicroRNA-720
Gene expression
Measured: Baseline and three months
CXCL8
Cytokine level
Measured: Baseline and three months
CXCL1
Cytokine level
Measured: Baseline and three months
April
Cytokine level
Measured: Baseline and three months
TH-17
Cell counting
Measured: Baseline and three months
TReg
Cell counting
Measured: Baseline and three months
Ly.B
Cell counting
Measured: Baseline and three months
MicroRNA-155
Gene expression
Measured: Baseline and three months
MicroRNA-146a
Gene expression
Measured: Baseline and three months
MicroRNA-16
Gene expression
Measured: Baseline and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 May 2019
- Primary completion21 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mojgan Mohammadi, Mashhad University of Medical Sciences
- Investigators
- Mojgan Mohammadi, Ph.D, Principal investigator, Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715140
- Sponsor's protocol ID
- IR.MUMS.MEDICAL.REC.1397.118
- Status last verified
- Feb 2020
- First submitted
- 15 Oct 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Preferring the data to remain confidential
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Crucumin Effects on the Cellular and Humoral Immune Systems in Osteoarthritis Patients; a Randomised Double Blind Placebo Control Clinical Trial
- ClinicalTrials.gov ID
- NCT03715140
- Acronym / sponsor ID
- IR.MUMS.MEDICAL.REC.1397.118
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Crucumin, Flowcytometry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 21 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 23 Oct 2018 (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.
In this study, the effects of crucumin on cellular and humoral immune system in patients with osteoarthritis will be investigated. Concentration of CXCL8, April, CX3CL1 and IL-17 will be evaluated with ELISA. TH-1, TH-17, TReg and Ly.B cells count will be measured by Flowcytometry. MicroRNA-720, MicroRNA-155, MicroRNA-16 and MicroRNA-146a gene expression will be measured with Real Time PCR technique.
Detailed description
The purpose of this study was to evaluate the effect of the active ingredient of crucumin on the reduction of symptoms of osteoarthritis. Of the 30 patients participating in this study, a blood sample will be taken at the beginning of the study, and then after three months of taking the crucumin. To evaluate the response to treatment, after each person sampling, we will analyze cell count for Th-1, Th-17, TReg and Ly.B by flowcytomtry method. Also we will measure cytokines level of IL-17, CXCL8, CX3CL1 and April by ELISA method. Finally we evaluate the gene expression of MicroRNA-720, MicroRNA-155, MicroRNA-146a and MicroRNA-16 by Real Time PCR technique.
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 |
|---|---|---|
| Patients who will recieve crucumin | Experimental | Drug: Crucuminpatients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug. |
| Patients who will receive placebo | Placebo comparator | Drug: PlaceboPatients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis patients who have been diagnosed with a rheumatologist physician based on clinical examinations and laboratory tests
Key exclusion criteria (1 listed)
- Affected by any other acute or chronic underlying disease
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 |
|---|---|---|
| CrucuminAlso: nanocrucuminEvaluation of the effect of Crucumin in patients with osteoarthritis | Drug | Patients who will recieve crucumin |
| PlaceboAlso: Crucumin placeboPlacebo | Drug | Patients who will receive placebo |
Primary outcome
IL-17
Time frame: Baseline
Cytokine level
12 secondary outcomes
IL-17
Time frame: Baseline and three months
TH-1
Time frame: Baseline and three months
MicroRNA-720
Time frame: Baseline and three months
CXCL8
Time frame: Baseline and three months
CXCL1
Time frame: Baseline and three months
April
Time frame: Baseline and three months
TH-17
Time frame: Baseline and three months
TReg
Time frame: Baseline and three months
Ly.B
Time frame: Baseline and three months
MicroRNA-155
Time frame: Baseline and three months
MicroRNA-146a
Time frame: Baseline and three months
MicroRNA-16
Time frame: Baseline and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Individual participant dataSharing planned: Undecided. Preferring the data to remain confidential
Related trials for Osteoarthritis
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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.
Mojgan Mohammadi, Ph.D principal investigator
Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crucumin in people with Osteoarthritis, run by Mashhad 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 1 inclusion and 1 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 19 Feb 2020. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Mojgan Mohammadi, Ph.D (0098 51 38012762, mozhganmohammadi69@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-17 (time frame: Baseline). 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 19 Feb 2020.