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Crocin Supplementation in CSCR

Primary Purpose

Chorioretinopathy, Central Serous

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Crocin
Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorioretinopathy, Central Serous

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Shiraz University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Crocin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected visual acuity (BCVA)

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2021
Last Updated
October 27, 2021
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04936490
Brief Title
Crocin Supplementation in CSCR
Official Title
Efficacy and Safety of Crocin Supplementation in Patients With Central Serous Chorioretinopathy (CSCR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorioretinopathy, Central Serous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crocin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Crocin
Intervention Description
15 mg/d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
15 mg/d
Primary Outcome Measure Information:
Title
Best-corrected visual acuity (BCVA)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Foveal thickness (μm)
Description
measured by OCT imaging
Time Frame
8 weeks
Title
Subretinal fluid height (μm)
Description
measured by OCT imaging
Time Frame
8 weeks
Title
Subfoveal choroidal thickness (μm)
Description
measured by OCT imaging
Time Frame
8 weeks
Title
Number of participants need to laser therapy
Description
based on clinical criteria
Time Frame
8 weeks
Title
Total number of reported adverse events
Description
based on patients reported adverse events
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mojtaba Heydari, M.D.
Phone
+989172051798
Email
mheydari@sums.ac.ir

12. IPD Sharing Statement

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Crocin Supplementation in CSCR

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