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Effects of ‍ Crocin on Diabetic Retinopathy and Cataract; A Double Blind Placebo Controlled Randomized Clinical Trial

Protocol summary

Summary
Diabetic retinopathy is one of the most eye complications in diabetic patients. Studies have shown that saffron extract contains numerous compounds, including crocin, which is the main active ingredient in saffron and is mostly observed as crocetin glycosides. Due to anti-inflammatory and antioxidant properties, crocin can be used in the treatment and prevention of diabetic maculopathy, cataract and eye diseases, which inflammatory and oxidative mechanisms are involved in their pathogenesis. In this study, 60 patients with diabetic maculopathy were studied in 3 groups. These groups included patients with 5 mg per day of crocin, patients with 15 mg per day of crocin and patients with placebo, respectively. Patients initially undergo a complete ophthalmic examination and the central macular thickness is measured using OCT spectralis. Immediately after three months of crocin prescription, the patients undergo a complete ophthalmic examination and OCT. Data obtained before and after treatment are compared, as well the results are compared with the control group. According to the specialist as well as for the healing integration process, patients whom their central macular thickness is close to each other’s will be selected in the placebo and treated groups. Also, they are under the same standard treatment (laser or Austin or steroids). Therefore, the results will be reliable.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062113058N2
Registration date: 2015-07-24, 1394/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Seyed Ahmad Mohajeri
Name of organization / entity
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
Mashhad University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ‍ Crocin on Diabetic Retinopathy and Cataract; A Double Blind Placebo Controlled Randomized Clinical Trial
Public title
Effects of ‍ Crocin on Diabetic Retinopathy and Cataract
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adult patients (18 ≤) with type 1 and 2 diabetes and CSME (clinically significant macular edema) according to ETDRS criteria (early treatment diabetic retinopathy study) in the studied eye, or patients who are diagnosed with cataract as well as central macular thickness in OCT above 296 microns, well controlled diabetes mellitus (HbA1c less than or equal to 8.5 over the last 3 months), and the ability to understand overview of the study, treatment and possible side effects. For cataract patients:Patients who are scheduled to undergo cataract surgery in the next 3 months and are not in a state of emergency. Grading based on a 0 to 4, according to criteria:0 = lens normal, clear, 1 = lens shows a slight blur, 2 = lens represents darkness average, 3 = lens represents the darkness of and the details are, 4 = Lens indicator cataract is done Exclusion criteria: 1. Presence of other eye abnormalities (non-retina causes, etc.) that despite an improvement in macular edema, do not improve visual acuity. 2. Other eye diseases (retinal vein occlusion, uveitis, retinal epithelial membrane) that can affect macular edema. 3. Patients with anterior segment abnormalities of the eye (cornea, anterior chamber, iris, or lens) 4. History of vitrectomy 5. Subfoveal hard exudates deposition 6. Existence treatment required PDR 7. Intraocular surgery within the last 3 months 8. Pregnancy 9. Vitreous hemorrhage
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study of patients in the treatment groups and the placebo group are randomly assigned . Doctors have no information of intervention .

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Deputy of Science and Technology, Mashhad University of Medical Sciences, next to the Hoveizeh cinema, Daneshgah Avenue
City
Mashhad
Postal code
Approval date
2014-12-10, 1393/09/19
Ethics committee reference number
research/930361/1/1205

Health conditions studied

1

Description of health condition studied
Diabetic Retinophaty
ICD-10 code
*H36.0
ICD-10 code description
Diabetic Retinopathy

Primary outcomes

1

Description
Central Macular Thickness
Timepoint
Before Intervention, and After Three Months
Method of measurement
Spectralis OCT Device

2

Description
Measure The Opacity Of The Lens
Timepoint
At The Time Of The Visit And Once After Of The End Of Treatment Period
Method of measurement
Microscopes Equipped With Digital Cameras And Upper Ring Light

Secondary outcomes

1

Description
side effects of crocin
Timepoint
Before intervention,and three months later
Method of measurement
Questionnaire for side effect of crocin

Intervention groups

1

Description
Group 1:Included Patients With 5 mg per Day Of Crocin.
Category
Treatment - Drugs

2

Description
Intervention Group 2: Patients With 15 mg per Day Of Crocin.
Category
Treatment - Drugs

3

Description
DiabeticPpatients With Placebo For 3 Months Treatments.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam-al-Anbia Hospital
Full name of responsible person
Dr. Seyedeh Maryam Hosseini
Street address
Abotaleb Intersection toward Ferdosi Square, Mashhad-Iran
City
Mashhad

2

Recruitment center
Name of recruitment center
Khatam-al-Anbia Hospital
Full name of responsible person
Dr. Siamak Zarei Ghanavati
Street address
Abotaleb Intersection toward Ferdosi Square, Mashhad-Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ahmad Mohajeri, Dr. Mohsen Tafaghodi
Street address
Shahid Fakori Blvd., Between shahis Javan and Shahid Al-Shahidi, Mashhad
City
Mashahad
Grant name
مشارکت 80 درصدی اعتبار پژوهشی مجری طرف قرارداد و .20 درصدی اعتبار مرکز تحقيقات دارورساني هدفمند
Grant code / Reference number
930361
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Seyed Ahmad Mohajeri
Position
PhD in Pharmacology, Faculty Member of Pharmacodynamy and Toxicology, School of Pharmacy and Targete
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
+98 38823251
Email
mohajeria@mums.ac.ir
Web page address
http://pharmacy.mums.ac.ir/index.php

Person responsible for scientific inquiries

Contact
Name of organization / entity
PhD in Pharmacology, Faculty Member of Pharmacodynamy and Toxicology, School of Pharmacy and Targete
Full name of responsible person
Dr. Seyed Ahmad Mohajeri
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
9196773117
Phone
+98 51 3882 3255
Fax
Email
mohajeria@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University Of Medical Science
Full name of responsible person
Samaneh Sepahi
Position
PhD By Research Student
Other areas of specialty/work
Street address
BuAli Research Institute, BuAli Square, Mashhad -Iran, and Mashhad University of Medical Science-Pharmacy School
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
sepahis931@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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