Crocin Supplementation in CSCR

Phase 1

• Conditions: Chorioretinopathy, Central Serous
• Interventions: Drug: Placebo; Drug: Crocin

• Registration Number: NCT04936490
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-23
• Study Start: 2021-07-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-28
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Crocin	Crocin	-

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity (BCVA)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Total number of reported adverse events	8 weeks	based on patients reported adverse events
Foveal thickness (μm)	8 weeks	measured by OCT imaging
Subfoveal choroidal thickness (μm)	8 weeks	measured by OCT imaging
Subretinal fluid height (μm)	8 weeks	measured by OCT imaging
Number of participants need to laser therapy	8 weeks	based on clinical criteria

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of