Crocin Supplementation in CSCR

Shiraz University of Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Chorioretinopathy, Central Serous

Treatments: Drug: Crocin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04936490

1400.059

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Crocin

Experimental group

Treatment:

Drug: Crocin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo