Evaluation of the effect of crocin on macular, peripapillary and optic nerve head blood flow in healthy individuals using coherence tomography optical angiography (OCTA)
The goal of this study is to perform a double blinded clinical trial to evaluate the therapeutic effect of crocin on macular, peripapillary and optic nerve head blood flow.
Design
This is a double blinded randomized clinical trial with two-arm parallel group. The crocin and placebo tablets are made in similar shape, color, and size. The macular, peripapillary and optic nerve head blood flow will be determined before and two hours after taking two tablets of crocin or placebo.
Settings and conduct
Study will be done in ِKhatam-al-Anbia Hospital under the supervision of specialist. Tablets will be prepared from pure crocin in Mashhad Pharmacy School. In this double blinded trial physician, participants and researchers will not aware of the pill contents. After selecting the participants they will be randomly divided into crocin or placebo groups. The macular, peripapillary and optic nerve head blood flow will be determined before and two hours after taking two tablets of crocin or placebo.
Participants/Inclusion and exclusion criteria
The age between 20 and 50
Lack of systemic disease such as diabetes and hypertension
Not using systemic drugs
Lack of any intraocular pathology
No history of eye surgery
Intervention groups
Healthy people who their retinal blood flow are examined before and 2 hours after receiving two crocin tablets (15 mg).
Placebo group: Healthy people who their retinal blood flow are examined before and two hours after receiving two placebo tablets.
Pharmaceutical Research Center, School Of Pharmacy, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohajeria@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of crocin on macular, peripapillary and optic nerve head blood flow in healthy individuals using coherence tomography optical angiography (OCTA)
Public title
The effect of crocin on retinal arteries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the volunteer should be between 20 and 50
Lack of systemic disease such as diabetes and hypertension
Do not use systemic drugs
Lack of any intraocular pathology
No history of eye surgery
Exclusion criteria:
Any eye disease
Age less than 20 or more than 50
History of eye surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
four-digit numbers, obtained from “random number table”, will be applied for coding of tablet containers and randomization. First column of the random number table will be assigned to crocin group and the second one to placebo. The codes will be written on a piece of paper and put into an opaque envelope. The envelopes will be sealed and placed sequentially in a box and kept by researcher and physician. Envelopes and their code will be assigned sequentially to eligible participants in order of their arrival time.
Blinding (investigator's opinion)
Double blinded
Blinding description
Crocin and placebo tablets will be prepared in a similar shape, color, and size, stored in a dark container and coded by a pharmacist. The physician, researcher, and participants will not be aware of the content of the pills inside the container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Pharmacy, Ferdowsi University complex, Azadi square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-05-01, 1399/02/12
Ethics committee reference number
IR.MUMS.REC.1399.212
Health conditions studied
1
Description of health condition studied
The blood flow of the macula, peripapillary and head of optic nerve
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Macular blood flow
Timepoint
Before the intervention and two hours after taking 2 tablets of 15 mg crocin or placebo
Method of measurement
Coherence Optical Tomography Angiography (OCTA)
Secondary outcomes
1
Description
blood flow of peripapillary and optic nerve head
Timepoint
Before the intervention and two hours after taking two tablets of crocin or placebo
Method of measurement
Coherence Optical Tomography Angiography (OCTA)
Intervention groups
1
Description
Intervention group: Two crocin tablets (15 mg) will be given into healthy participants in the project. Optical coherence tomography (OCT) imaging with angiography will be done before and after two hours of crocin administration.
Category
Treatment - Drugs
2
Description
Control group: Two placebo tablets will be given into healthy participants in the project. Optical coherence tomography (OCT) imaging with angiography will be done before and after two hours of placebo administration, .