Evaluation of the effect of Garlic tablet as a complementary treatment of macular edema of patients with diabetic retinopathy in comparison with placebo, double blind randomized placebo controlled clinical trial
Determination of the effect of Garlic tablet as a complementary treatment of macular edema of patients with diabetic retinopathy in comparison with placebo.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 96 patients
Patients are divided into two groups by blocked randomization method and using a random number tables.
Settings and conduct
Patients are selected from Poostchi clinic and were randomly assigned to two groups: case and control. All patients receive standard treatment for macular diabetic edema (intravenous injection of Bevacizumab and retinal laser) under the supervision of a physician. The therapist has no information about the case and control individuals. In the pharmacy setting, patients on the case group are given garlic tablets at a dose of 1000 mg daily for 4 weeks. The other group is given a placebo in the form of a pill with the same packaging as the Garlic supplement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetic patients with macular edema
Exclusion criteria:
1)Oral or intravenous injection of corticosteroids and Immunomodulatory therapy
2)History of vitrectomy surgery
3)Warfarin and Plavix and any blood thinners Consumption
4)History of rheumatic disease, renal failure, chemotherapy and active gastrointestinal ulcers
Intervention groups
Intervention group: Patients in the intervention group receive Garlic tablet with a dose of 1000 mg daily for 1 month. (from the pharmaceutical company Garsin that containing the active ingredient allin and allicin) for 1 month.
Control group: Patients in the control group receive placebo tablet daily for 1 month.
After 1 month, the best corrected visual acuity and optical coherence tomography is performed and macula thickness is measured in both group.
Main outcome variables
Best corrected visual acuity
Optical coherence tomography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047083N1
Registration date:2020-07-14, 1399/04/24
Registration timing:retrospective
Last update:2020-07-14, 1399/04/24
Update count:1
Registration date
2020-07-14, 1399/04/24
Registrant information
Name
Mehrdad Afarid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3629 1779
Email address
afaridm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Garlic tablet as a complementary treatment of macular edema of patients with diabetic retinopathy in comparison with placebo, double blind randomized placebo controlled clinical trial
Public title
Evaluation of the effect of Garlic tablet as a treatment of macular edema of patients with diabetic retinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients with macular edema
Exclusion criteria:
Oral or intravenous injection of corticosteroids and Immunomodulatory therapy
History of vitrectomy surgery
Warfarin and Plavix and any blood thinners Consumption
History of rheumatic disease, renal failure, chemotherapy and active gastrointestinal ulcers
Age
From 25 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups by blocked randomization method and using a random number tables.
In this test, patients are divided into 12 blocks which contain 8 patient based on random numbers.Then the blocks are divided into two groups based on a random table of numbers. For using random number table, first we should pre-determine the direction of reading the numbers. For example up, down, left and right. Then we have to consider the numbers for different groups. Then we chose one number and follow the pre-specified direction and record the numbers and allocate to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients were randomly assigned to two groups: case and control. All patients receive standard treatment for macular diabetic edema (intravenous injection of Bevacizumab and retinal laser) under the supervision of a physician. The therapist has no information about the case and control individuals. In the pharmacy setting, patients on the case group are given garlic tablets at a dose of 1000 mg daily for 4 weeks. The other group is given a placebo in the form of a pill with the same packaging as the Garlic supplement.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz,
City
Shiraz
Province
Fars
Postal code
7134997446
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.SUMS.MED.REC.1399.052
Health conditions studied
1
Description of health condition studied
Macular edema in patients with type 2 diabetes
ICD-10 code
E11.311
ICD-10 code description
Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
Primary outcomes
1
Description
Macula thickness
Timepoint
Before starting the intervention and 1 month later after taking garlic tablets and placebo
Method of measurement
Optical coherence tomography
Secondary outcomes
1
Description
Best Corrected Visual Acuity
Timepoint
Before starting the intervention and 1 month later after taking garlic tablets and placebo
Method of measurement
Snellen chart
Intervention groups
1
Description
Intervention group: A complete examination of the anterior and posterior segments is performed for patients in this group. and the best corrected visual acuity is measured based on the Snellen chart, and optical coherence tomography is done for all the patients. All patients receive standard treatment for macular diabetic edema (intravenous injection of Boasizumab and retinal laser). Patients in the intervention group receive Garlic tablet with a dose of 1000 mg daily with lunch for 1 month. (from the pharmaceutical company Garsin that containing the active ingredient allin and allicin) daily with lunch for 1 month.After 1 month, the best corrected visual acuity and optical coherence tomography is performed and macula thickness is measured.
Category
Treatment - Drugs
2
Description
Control group: A complete examination of the anterior and posterior segments is performed for patients in this group. and the best corrected visual acuity is measured based on the Snellen chart, and optical coherence tomography is done for all the patients. All patients receive standard treatment for macular diabetic edema (intravenous injection of Boasizumab and retinal laser). Patients in the control group receive placebo tablet daily with lunch for 1 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poostchi Ophthalmology Training and Treatment Center
Full name of responsible person
Mehrdad Afarid
Street address
Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3233 0073
Email
afaridm@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Afarid
Street address
Shiraz University of Medical Sciences, central building, Zand Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdeo@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Afarid
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
0987132330073
Email
afaridm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Afarid
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
0987132330073
Email
afaridm@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Afarid
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
0987132330073
Fax
Email
afaridm@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have not been identified.
When the data will become available and for how long
The access period starts 6 months after the results are printed.
To whom data/document is available
Data will only be available to researchers working at academic and scientific institutions.
Under which criteria data/document could be used
Requires a request from the responsible author and in each case a separate decision is made.
From where data/document is obtainable
Mehrdad Afarid. Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz.
Post code: 7134997446
Pone number: +98 71 3233 0073
afaridm@sums.ac.ir
What processes are involved for a request to access data/document
After reviewing the request, the answer will be given within 1 month.