Protocol summary
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Study aim
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Determination the effect of Garlic tablet as a complementary treatment of macular edema in diabetic retinopathy patients compared with placebo.
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Design
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Clinical trial with control group, double-blind, randomized, on 96 patients
Patients are divided into two groups by using a random numbers .
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Settings and conduct
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Patients are selected from Shiraz clinics and were randomly assigned to two groups: case and control. All patients receive standard treatment for macular diabetic edema (intravenous injection of Bevacizumab or retinal laser) under the supervision of a physician. The therapist has no information about the case and control individuals. patients on the case group are given garlic tablets at a dose of 1000 mg daily for 4 weeks (2or 3 months if possible for some patients). The other group is given a placebo in the form of a pill with the same packaging as the Garlic supplement.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 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 Heparin
4) History of chemotherapy and active gastrointestinal ulcers
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Intervention groups
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Intervention group: Patients receive Garlic tablet with a dose of 1000 mg daily
Control group: Patients in the control group receive placebo tablet daily.
After 1 month, the best corrected visual acuity and optical coherence tomography is performed and macula thickness is measured in both groups.
Treatment duration: 1 months (if possible for some patients 2 or 3 months).
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Main outcome variables
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Best corrected visual acuity
Optical coherence tomography
General information
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Reason for update
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If possible the period of intervention will be extended up to 1or 2 months for some of the volunteers.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200415047083N1
Registration date:
2020-07-14, 1399/04/24
Registration timing:
prospective
Last update:
2020-10-10, 1399/07/19
Update count:
1
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Registration date
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2020-07-14, 1399/04/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-22, 1399/05/01
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Expected recruitment end date
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2021-08-22, 1400/05/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluation of the effect of Garlic tablet as a treatment of macular edema of patients with diabetic retinopathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diabetic patients with macular edema
Exclusion criteria:
Oral or intravenous injection of corticosteroids and Immunomodulatory therapy
History of vitrectomy surgery
Warfarin and Plavix and Heparin
History of chemotherapy and active gastrointestinal ulcers
History of cerebral hemorrhage
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
96
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In each clinic a random number (for example between 0-1) is produced by calculator or computer for each patient and if this number is lower than a limit number ( for example 0.5) that patient is selected as a case and if upper as a control or viceversa.
Or : A number is allocated to each patient .Random numbers( equal to number of case or control group) produced by using calculator or computer .Patients are divided into two groups by using random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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 or retinal laser) under the supervision of a physician. The therapist has no information about the case and control individuals.patients on the case group are given garlic tablets at a dose of 1000 mg daily for 4 weeks (if possible 2or 3 months for some patients). The other group is given a placebo in the form of a pill with the same packaging as the Garlic supplement.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-26, 1399/02/07
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Ethics committee reference number
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IR.SUMS.MED.REC.1399.052
Health conditions studied
1
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Description of health condition studied
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Macular edema in patients with diabetes
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ICD-10 code
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E11.311
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ICD-10 code description
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Diabetes mellitus with unspecified diabetic retinopathy with macular edema
Primary outcomes
1
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Description
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Macula thickness
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Timepoint
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Before starting the intervention and 1 month later after taking garlic tablets and placebo
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Method of measurement
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Optical coherence tomography
Secondary outcomes
1
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Description
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Best Corrected Visual Acuity
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Timepoint
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Before starting the intervention and 1 month later after taking garlic tablets and placebo
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Method of measurement
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Snellen chart
Intervention groups
1
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Description
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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 or retinal laser). Patients in the intervention group receive Garlic tablet with a dose of 1000 mg daily with lunch for 1 month (if possible for some patients 2 or 3 months).After 1 month, the best corrected visual acuity and optical coherence tomography is performed and macula thickness is measured.
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Category
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Treatment - Drugs
2
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Description
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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 or retinal laser). Patients in the control group receive placebo tablet daily with lunch for 1 month (if possible for some patients 2 or 3 months).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available