the aim of this Double blind Clinical Trial is Determination of the Monotherapy Therapeutic Effects of Crocin on Patients with Maculopathy
Design
In this double blind randomized trial with two arm parallel group, the Crocin and Placebo Tablets are made in completely similar shape, color, and size
Settings and conduct
Study will be conducted in ِKhatam-al-Anbia Hospital under the supervision of specialized doctors, Tablets will be produced from pure Crocin at Mashhad Pharmacy School. In this trial, physician, researcher, patient, and the test analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Patients with mild to moderate Maculopathy that center has not been involved, Best corrected visual acuity equal or upper than 8/10 according to Snellen chart, Diabetes mellitus with HbA1c 5.8-7 during last 3 months, No need for standard treatment including Injection, The ability to understand the study, The Maximum Severity of DR be non- Proliferative Step, Blood Pressure is controlled.
Intervention groups
Treatment group 1: patients with Diabetic Mculopathy that used (15 mg per day) of crocin Tablet for 3 months. Crocin is a herbal product and an active constitute of saffron. Placebo group: patients with Diabeti Maculopathy that used one Placebo Tablet per day for 3 months.
Main outcome variables
Macular Thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130418013058N13
Registration date:2019-07-30, 1398/05/08
Registration timing:registered_while_recruiting
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
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
Expected recruitment start date
2018-12-31, 1397/10/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Monotherapy effect of Crocin on mild to moderate maculopathy; a clinical trial study
Public title
Effect of Crocin on mild to moderate maculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate Maculopathy that center has not been involved
Best corrective visual acuity equal or upper than 8/10 according to Snellen chart
Diabetes mellitus with HbA1c 5.8-7 during 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 ability to understand the study, interventions and possible complications
The Maximum Severity of Diabetic Retinopathy be non- Proliferative Step
Blood Pressure is controlled
Exclusion criteria:
The presence of other ophthalmic conditions
Another eye disease that can affect macular edema (Retinal vein occlusion, uveitis)
Patients with anterior segmentation of the eye disorders
History of vitrectomy surgery
The presence of subfoveal hard exudates deposition
History of intraocular surgery in the last 3 months
Age
From 18 years old to 80 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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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)
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 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
Ethics committee of 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
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.MUMS.REC.1397.207
Health conditions studied
1
Description of health condition studied
Diabetic Retinopathy
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
Secondary outcomes
1
Description
FBS Level
Timepoint
Before intervention,and three months later
Method of measurement
FBS Level Test
Intervention groups
1
Description
Intervention group: Receiving One Tablet of Crocin (15 mg)daily for three Months
Category
Treatment - Drugs
2
Description
Control group: Receiving One Tablet of Placebo daily for three Months