Osteoarthritis, KneePhase 3NCT03375814
Evaluation Effect of Crocina on The Cellular Immune Responses in Osteoarthritis Patients
A Phase 3 study testing Crocin in people with Osteoarthritis, Knee, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The effect of Crocina on the production of IL-4, IL-1 bet, IL-17, IL-10 and TGF-beta: The effect of crocina on gene expression of transcription factors T-bet, GATA-3. FOXP3, ROR-γt,; The effect of helper T cells type one and two, regulatory T cells and T helper type 17 cells; the effect of crocina on the reduction of… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Crocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 20 Jul 2016to 30 Jul 2018
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Osteoarthritis patients must have
- Aged 40 to 75.
- The severity of joint damage between grade 2 and grade 3 based on radiographic images.
- No history of joint surgery.
- No history of injury.
- No diabetic disorders.
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- No rheumatism.
- No kidney disease.
- No osteonecrosis and gout.
- No long history of anti-inflammatory drugs consumption.
- No insufferable jobs;
- The Body Mass Index (BMI) of 30 or less.
Who cannot join
- Osteoarthritis patients should not have:
- Aged less than 40 and more than 75
- With the severity of joint damage of the in grade 1 and grade 4 based on radiographic images.
- With history of joint surgery.
- With history of injury
- With diabetic disorders, rheumatism, kidney disease, osteonecrosis and gout.
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- With long history of anti-inflammatory drugs consumption.
- Having insufferable jobs.
- With a BMI of 30 or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Crocina on The Cellular Immune Responses in Patients With Osteoarthritis as Randomized, Double-blind and Placebo Controlled
The effect of Crocina on the production of IL-4, IL-1 bet, IL-17, IL-10 and TGF-beta: The effect of crocina on gene expression of transcription factors T-bet, GATA-3. FOXP3, ROR-γt,; The effect of helper T cells type one and two, regulatory T cells and T helper type 17 cells; the effect of crocina on the reduction of pain and joint inflammation. Design: Randomized, Double-blind and Placebo controlled; Study population: Patients with Osteoarthritis; Volume: 40 persons; Method: Osteoarthritis patients will be divided into two groups according to age and sex; Crocina tablets will be prescribed to the first group a tablet 15 mg daily along with conventional Medicines; Placebo tablets will be prescribed to the second group along with the conventional medicines; Blood sampling of patients will be done before drug administering and four months after treatment. Major Inclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage between grade 2 and 3; Patients without history of injury; Patients with body mass index less than 30. Major Exclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage in grade one and four; Patients with history of injury and body mass index 30 or more. Intervention: Treatment with prescription of drug at dose of 15 mg daily crocin in the study group and placebo in the control group. Time: 4 months; Main outcome Measures: Osteoarthritis, Pain, Inflammation, Crocina, IL-4, IL-1 beta, IL-17, IL-10, TGF- beta, Cell surface protein CD127, The expression of T-bet, GATA-3, FOXP3, ROR-γt and the number of Th1, Th2, T-regulatory and Th17.
Read the detailed description
The effect of crocina on the production of IL-4, IL-1β, IL-17, IL-10 and TGF-β by ELISA assay;The effect of crocina on gene expression of transcription factors T-bet, GATA3, FOXP3, ROR-γt by Real-Time PCR; The effect of crocina on number of helper T cells type one and two, regulatory T cells and T helper type 17 cells by Flow Cytometry analysis; The effect of crocina on the reduction of pain and joint inflammation by WOMAC osteoarthritis index, vas score pain and CRP, ESR diagnostic tests . Design: Randomized, Double-blind and Placebo controlled; Study population: Patients with Osteoarthritis; Volume: 40 persons; Method: Osteoarthritis patients will be divided into two groups according to age and sex; Crocina tablets will be prescribed to the first group a tablet 15 mg daily along with the conventional medicines. 30 pills of crocina or placebo in cans quite similar and be encoded with Excel Software will be given to the patients completely random; The distributor and the patient will have no knowledge of the contents of the cans; After the end of each month, the patients will receive similar to their previous code. Blood sampling of patients will be done before drug administering and four months after the treatment. Major Inclusion Criteria: Osteoarthritis patients with age 40 to 75 years; The severity of joint damage between grade 2 and 3; Patients without history of injury; Patients with the Body Mass Index (BMI) less than 30. Major Exclusion Criteria: Osteoarthritis patients with age less than 40 and more than 75; The severity of joint damage in the grade one and four; Patients with history of injury and body mass index 30 or more. Intervention: Treatment with prescription of drug at dose of 15 mg daily crocin in the study group and placebo in the control group; Time: 4 months. Main Outcome Measures: Osteoarthritis, Pain, Inflammation, Crocin, IL-4, IL-1 beta, IL-17, IL-10, TGF-beta, Cell surface CD127, The expression of T-bet; GATA3; FOXP3; RORgt and the number of Th1, Th2, T-regulatory and Th17
- Conditions
- Osteoarthritis, Knee
- Being tested
- Crocin, Placebo Oral Tablet
- Keywords
- Crocin, osteoarthritis, Inflammation, IL-17,T-helper,T-reg
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrocinDrug
Also called Test group
This group (osteoarthritic patients) can receive crocin with conventional therapy
Placebo Oral TabletDrug
Also called Control group
The group that takes Placebo Oral Tablet. They received the conventional treatment and Placebo Pills..
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The group that takes the main drug. They received the conventional treatment group and crocin. Receives: Drug: Crocin |
| Placebo group | Placebo comparator | The group that takes the Placebo. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic report from knee
Patients suffering from osteoarthritis are classified in grades 1 to 4 and grades 2 and 3 will be enter to study.
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start20 Jul 2016
- Primary completion2 Mar 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Osteoarthritis patients who have age between 40 to 75 years old will be selected; Based on radiographic images of patients the severity of joints damage will get detailed and they will be placed in between grade 2 and grade 3 in terms of gradation; these patients will be not located underwent surgery; Patients will complete WOMAC and KOOS questionnaires to obtain some information such as following items; They will be no history of injury; they will not have diabetic disorders, rheumatism and kidney disease, osteonecrosis, gout; they will not have a long history anti-inflammatory drugs consumption; They will not have individuals with insufferable jobs carrying heavy loads; Patients will not have the Body Mass Index (BMI) of 30 or more
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shariati Jaleh, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375814
- Sponsor's protocol ID
- 931577
- Status last verified
- Dec 2017
- First submitted
- 12 Oct 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mohebbi M, Atabaki M, Tavakkol-Afshari J, Shariati-Sarabi Z, Poursamimi J, Mohajeri SA, Mohammadi M. Significant Effect of Crocin on the Gene Expression of MicroRNA-21 and MicroRNA-155 in Patients with Osteoarthritis. Iran J Allergy Asthma Immunol. 2022 Jun 18;21(3):322-331. doi: 10.18502/ijaai.v21i3.9805.
PubMed 35822682
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Crocina on The Cellular Immune Responses in Patients With Osteoarthritis as Randomized, Double-blind and Placebo Controlled
- ClinicalTrials.gov ID
- NCT03375814
- Acronym / sponsor ID
- 931577
- Conditions
- Osteoarthritis, Knee
- Keywords
- Crocin, osteoarthritis, Inflammation, IL-17,T-helper,T-reg
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 2 Mar 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 18 Dec 2017 (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.
The effect of Crocina on the production of IL-4, IL-1 bet, IL-17, IL-10 and TGF-beta: The effect of crocina on gene expression of transcription factors T-bet, GATA-3. FOXP3, ROR-γt,; The effect of helper T cells type one and two, regulatory T cells and T helper type 17 cells; the effect of crocina on the reduction of pain and joint inflammation. Design: Randomized, Double-blind and Placebo controlled; Study population: Patients with Osteoarthritis; Volume: 40 persons; Method: Osteoarthritis patients will be divided into two groups according to age and sex; Crocina tablets will be prescribed to the first group a tablet 15 mg daily along with conventional Medicines; Placebo tablets will be prescribed to the second group along with the conventional medicines; Blood sampling of patients will be done before drug administering and four months after treatment. Major Inclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage between grade 2 and 3; Patients without history of injury; Patients with body mass index less than 30. Major Exclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage in grade one and four; Patients with history of injury and body mass index 30 or more. Intervention: Treatment with prescription of drug at dose of 15 mg daily crocin in the study group and placebo in the control group. Time: 4 months; Main outcome Measures: Osteoarthritis, Pain, Inflammation, Crocina, IL-4, IL-1 beta, IL-17, IL-10, TGF- beta, Cell surface protein CD127, The expression of T-bet, GATA-3, FOXP3, ROR-γt and the number of Th1, Th2, T-regulatory and Th17.
Detailed description
The effect of crocina on the production of IL-4, IL-1β, IL-17, IL-10 and TGF-β by ELISA assay;The effect of crocina on gene expression of transcription factors T-bet, GATA3, FOXP3, ROR-γt by Real-Time PCR; The effect of crocina on number of helper T cells type one and two, regulatory T cells and T helper type 17 cells by Flow Cytometry analysis; The effect of crocina on the reduction of pain and joint inflammation by WOMAC osteoarthritis index, vas score pain and CRP, ESR diagnostic tests . Design: Randomized, Double-blind and Placebo controlled; Study population: Patients with Osteoarthritis; Volume: 40 persons; Method: Osteoarthritis patients will be divided into two groups according to age and sex; Crocina tablets will be prescribed to the first group a tablet 15 mg daily along with the conventional medicines. 30 pills of crocina or placebo in cans quite similar and be encoded with Excel Software will be given to the patients completely random; The distributor and the patient will have no knowledge of the contents of the cans; After the end of each month, the patients will receive similar to their previous code. Blood sampling of patients will be done before drug administering and four months after the treatment. Major Inclusion Criteria: Osteoarthritis patients with age 40 to 75 years; The severity of joint damage between grade 2 and 3; Patients without history of injury; Patients with the Body Mass Index (BMI) less than 30. Major Exclusion Criteria: Osteoarthritis patients with age less than 40 and more than 75; The severity of joint damage in the grade one and four; Patients with history of injury and body mass index 30 or more. Intervention: Treatment with prescription of drug at dose of 15 mg daily crocin in the study group and placebo in the control group; Time: 4 months. Main Outcome Measures: Osteoarthritis, Pain, Inflammation, Crocin, IL-4, IL-1 beta, IL-17, IL-10, TGF-beta, Cell surface CD127, The expression of T-bet; GATA3; FOXP3; RORgt and the number of Th1, Th2, T-regulatory and Th17
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Osteoarthritis patients who have age between 40 to 75 years old will be selected; Based on radiographic images of patients the severity of joints damage will get detailed and they will be placed in between grade 2 and grade 3 in terms of gradation; these patients will be not located underwent surgery; Patients will complete WOMAC and KOOS questionnaires to obtain some information such as following items; They will be no history of injury; they will not have diabetic disorders, rheumatism and kidney disease, osteonecrosis, gout; they will not have a long history anti-inflammatory drugs consumption; They will not have individuals with insufferable jobs carrying heavy loads; Patients will not have the Body Mass Index (BMI) of 30 or more
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: CrocinThe group that takes the main drug. They received the conventional treatment group and crocin. |
| Placebo group | Placebo comparator | Drug: Placebo Oral TabletThe group that takes the Placebo. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Osteoarthritis patients must have
- Aged 40 to 75.
- The severity of joint damage between grade 2 and grade 3 based on radiographic images.
- No history of joint surgery.
- No history of injury.
Key exclusion criteria (9 listed)
- Aged less than 40 and more than 75
- With the severity of joint damage of the in grade 1 and grade 4 based on radiographic images.
- With history of joint surgery.
- With history of injury
- With diabetic disorders, rheumatism, kidney disease, osteonecrosis and gout.
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 |
|---|---|---|
| CrocinAlso: Test groupThis group (osteoarthritic patients) can receive crocin with conventional therapy | Drug | Experimental group |
| Placebo Oral TabletAlso: Control groupThe group that takes Placebo Oral Tablet. They received the conventional treatment and Placebo Pills.. | Drug | Placebo group |
Primary outcome
Radiographic report from knee
Time frame: 15 minute
Patients suffering from osteoarthritis are classified in grades 1 to 4 and grades 2 and 3 will be enter to study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Derived from this study: PubMed 35822682Mohebbi M, Atabaki M, Tavakkol-Afshari J, Shariati-Sarabi Z, Poursamimi J, Mohajeri SA, Mohammadi M. Significant Effect of Crocin on the Gene Expression of MicroRNA-21 and MicroRNA-155 in Patients with Osteoarthritis. Iran J Allergy Asthma Immunol. 2022 Jun 18;21(3):322-331. doi: 10.18502/ijaai.v21i3.9805.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Crocin in people with Osteoarthritis, Knee, 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 12 inclusion and 9 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 18 Dec 2017. 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?
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?
Radiographic report from knee (time frame: 15 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375814, which also lists 1 linked publication.
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 18 Dec 2017.