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Effect of Crocin on macular and optic nerve head vascular density in non-proliferative diabetic retinopathy patient with non-central macular involvement

Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210310050669N1
Registration date: 2021-03-14, 1399/12/24
Registration timing: prospective

Last update: 2021-03-14, 1399/12/24
Update count: 0
Registration date
2021-03-14, 1399/12/24
Registrant information
Name
Ali Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 1401
Email address
eslamia961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-17, 1399/12/27
Expected recruitment end date
2021-04-16, 1400/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Crocin on macular and optic nerve head vascular density in non-proliferative diabetic retinopathy patient with non-central macular involvement
Public title
Effect of Crocin on macular and optic nerve head vascular density in non-proliferative diabetic retinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (18 years and older) with type 2 diabetes without central involvement macular edema according to ETDRS criteria (early treatment diabetic retinopathy study) in the studied eye Best corrective visual acuity equal or upper than 7/10 (20/30) according to Snellen chart HbA1c has been 6.5-9.5 during the last 3 months No need for standard treatment including Injection, Macula Laser or Retina Laser The absence of other serious illnesses, such as liver and kidney failure The maximum severity of diabetic retinopathy be non- proliferative Controlled blood pressure or lipid profile in hypertension and hyperlipidemia patients if present
Exclusion criteria:
The presence of other ophthalmic diseases that effects macular edema (like Retinal vein occlusion, uveitis, Epiretinal membrane) Patients with anterior segmentation of the eye disorders (Cornea, anterior chamber, Iris, and lens) History of any intraocular surgery except cataract surgery (more than 6 months before entrance study) Sub foveal hard exudates deposition Pregnancy, Breast feeding Need for Standard treatment including Injection, Macula Laser, or Retina Laser Allergy to saffron The presence of other ophthalmic diseases that effects vision (glaucoma, vascular obstruction, macular pathology)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization For each tablet container, four-digit codes will be randomly labeled to each box by pharmacist . The therapist will give it to the patient randomly without knowledge of the type of medicine. Thus, the nature of each code will be unclear until the analysis of the results.
Blinding (investigator's opinion)
Triple 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 treating physician, researcher, and patients will not be aware of the code printed on the container.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee School of Medicine- Mashhad University of Medical Sciences
Street address
Khatam Ol-Anbia Eye Hospital, Abutaleb Junction, Ghareni blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178865898
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.804

Health conditions studied

1

Description of health condition studied
Diabetic Retinopathy
ICD-10 code
E11.3
ICD-10 code description
Type 2 diabetes mellitus with ophthalmic complications

Primary outcomes

1

Description
Macular and optic nerve head vascular density
Timepoint
Before intervention, and 3 months later
Method of measurement
Optovue Optical Coherence Tomography (OCT)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving one tablet of Crocin (15 mg)daily for 3 months
Category
Treatment - Drugs

2

Description
Control group: Receiving one tablet of placebo daily for three months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Ol-Anbia Eye Hospital
Full name of responsible person
Dr. Ali Eslami
Street address
Khatam Ol-Anbia Eye Hospital, Abutaleb Junction, Ghareni blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
eslamia961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Between shahis Javan and Shahid Al-Shahidi,Shahid Fakori Blvd., Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 1538
Email
vresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ali Eslami
Position
Resident of ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Khatam Ol-Anbia Eye Hospital, Abutaleb Junction, Ghareni blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
Email
eslamia961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Maryam Hosseini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khatam Ol-Anbia Eye Hospital, Abutaleb Junction, Ghareni blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
hoseinimm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ali Eslami
Position
Resident of ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Khatam Ol-Anbia Eye Hospital, Abutaleb Junction, Ghareni blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
Email
eslamia961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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