Chorioretinopathy, Central SerousPhase 1NCT04936490
Crocin Supplementation in CSCR
A Phase 1 study testing Crocin in people with Chorioretinopathy, Central Serous, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Preclinical and clinical evidence support the protective effect of crocin on different pathologic pathways involved in central serous chorioretinopathy (CSCR). They involve inflammation, oxidative stress, mineralocorticoid pathway, and also stress-related injuries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chorioretinopathy, Central Serous
- What is being tested?
- Crocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2021to 30 Nov 2021
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age of 18-60 years old
- The diagnosis of CSCR based on clinical and imagining evaluation
- informed consent
Who cannot join
- Chronic CSCR
- Laser treatment (6 months prior to enrollment)
- IVB treatment (3 months prior to enrollment)
- Other retinal diseases
- History of eye diseases
- Diabetes Mellitus
Show all 10Show fewer
- Renal or hepatic diseases
- Allergy to saffron or crocin
- Pregnancy or lactation
- Beta-blocker, diuretic, or corticosteroid (1 week prior to enrollment) Bleeding tendency or any coagulation disorder
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shiraz University of Medical Sciences
Shiraz, Fars
Mojtaba Heydari, M.D., +989172051798, mheydari@sums.ac.ir
About this study
Official title: Efficacy and Safety of Crocin Supplementation in Patients With Central Serous Chorioretinopathy (CSCR)
Preclinical and clinical evidence support the protective effect of crocin on different pathologic pathways involved in central serous chorioretinopathy (CSCR). They involve inflammation, oxidative stress, mineralocorticoid pathway, and also stress-related injuries. It also showed that crocin has a protective effect on the retinal pigmented epithelium (RPE) layer. Based on the mentioned evidence the study designed to evaluate the efficacy and safety of 2-month crocin supplementation (15 mg/d) in 40 patients with CSCR in a randomized controlled blinded clinical trial.
- Conditions
- Chorioretinopathy, Central Serous
- Being tested
- Crocin, Placebo
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrocinDrug
15 mg/d
PlaceboDrug
15 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Crocin | Experimental | Not described Receives: Drug: Crocin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA)
Measured: 8 weeks
Secondary outcomes (5)
Foveal thickness (μm)
measured by OCT imaging
Measured: 8 weeks
Subretinal fluid height (μm)
measured by OCT imaging
Measured: 8 weeks
Subfoveal choroidal thickness (μm)
measured by OCT imaging
Measured: 8 weeks
Number of participants need to laser therapy
based on clinical criteria
Measured: 8 weeks
Total number of reported adverse events
based on patients reported adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Jul 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chorioretinopathy, Central SerousStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mojtaba Heydari, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936490
- Sponsor's protocol ID
- 1400.059
- Status last verified
- Oct 2021
- First submitted
- 2 May 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Crocin Supplementation in Patients With Central Serous Chorioretinopathy (CSCR)
- ClinicalTrials.gov ID
- NCT04936490
- Acronym / sponsor ID
- 1400.059
- Conditions
- Chorioretinopathy, Central Serous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 23 Jun 2021 (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.
Preclinical and clinical evidence support the protective effect of crocin on different pathologic pathways involved in central serous chorioretinopathy (CSCR). They involve inflammation, oxidative stress, mineralocorticoid pathway, and also stress-related injuries. It also showed that crocin has a protective effect on the retinal pigmented epithelium (RPE) layer. Based on the mentioned evidence the study designed to evaluate the efficacy and safety of 2-month crocin supplementation (15 mg/d) in 40 patients with CSCR in a randomized controlled blinded clinical trial.
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 |
|---|---|---|
| Crocin | Experimental | Drug: Crocin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age of 18-60 years old
- The diagnosis of CSCR based on clinical and imagining evaluation
- informed consent
Key exclusion criteria (10 listed)
- Chronic CSCR
- Laser treatment (6 months prior to enrollment)
- IVB treatment (3 months prior to enrollment)
- Other retinal diseases
- History of eye diseases
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 |
|---|---|---|
| Crocin15 mg/d | Drug | Crocin |
| Placebo15 mg/d | Drug | Placebo |
Primary outcome
Best-corrected visual acuity (BCVA)
Time frame: 8 weeks
5 secondary outcomes
Foveal thickness (μm)
Time frame: 8 weeks
Subretinal fluid height (μm)
Time frame: 8 weeks
Subfoveal choroidal thickness (μm)
Time frame: 8 weeks
Number of participants need to laser therapy
Time frame: 8 weeks
Total number of reported adverse events
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Crocin in people with Chorioretinopathy, Central Serous, run by Shiraz 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 3 inclusion and 10 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 28 Oct 2021. 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 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (BCVA) (time frame: 8 weeks). 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 28 Oct 2021.