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Crocin Supplementation in CSCR

NCT ID: NCT04936490

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-11-30

Brief Summary

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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

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Conditions

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Chorioretinopathy, Central Serous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Crocin

Group Type EXPERIMENTAL

Crocin

Intervention Type DRUG

15 mg/d

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

15 mg/d

Interventions

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Crocin

15 mg/d

Intervention Type DRUG

Placebo

15 mg/d

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mojtaba Heydari

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Site Status RECRUITING

Countries

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Iran

Facility Contacts

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Mojtaba Heydari, M.D.

Role: primary

Other Identifiers

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1400.059

Identifier Type: -

Identifier Source: org_study_id