Efficacy and Safety of Crocin Supplementation in Patients With Central Serous Chorioretinopathy (CSCR)
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Best-corrected visual acuity (BCVA)
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age of 18-60 years old
- •The diagnosis of CSCR based on clinical and imagining evaluation
- •informed consent
Exclusion Criteria
- •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
- •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
Arms & Interventions
Crocin
Intervention: Crocin (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Best-corrected visual acuity (BCVA)
Time Frame: 8 weeks
Secondary Outcomes
- Total number of reported adverse events(8 weeks)
- Foveal thickness (μm)(8 weeks)
- Subfoveal choroidal thickness (μm)(8 weeks)
- Subretinal fluid height (μm)(8 weeks)
- Number of participants need to laser therapy(8 weeks)
Investigators
Mojtaba Heydari
Principal Investigator
Shiraz University of Medical Sciences