Protocol summary
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Study aim
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Determining The effect of garlic supplementation on markers of inflammation and oxidative stress in patients with diabetic nephropathy
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Design
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randomized clinical trial, double-blind, randomized control group of 60 patient. Randomization is done using a valid website and a 4-block method.
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Settings and conduct
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This clinical trial study will be performed in the office of a nephrologist. Researchers, participants will be unaware of the allocation of treatments.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diabetic nephropathy confirmed by a specialist, clinically in stage 3 (eGFR equal to 30 to 59) or stage 4 (eGFR equal to 15 to 29) chronic kidney disease not performing hemodialysis or peritoneal dialysis, lack presence of liver, gastrointestinal, stroke and ischemic heart disease (3 months after myocardial infarction and ischemia), pulmonary disease (asthma and COPD), cancer, hypothyroidism and hyperthyroidism, gastric ulcer, infectious Especially hepatitis, allergy to garlic No pregnancy and lactation, not consuming anticoagulants such as heparin, warfarin, apixaban, yuaroxaban, penicillamine and 3 months after taking antibiotics No history of taking garlic supplements and no special diet in the last 3 months, no smoking, being in the age range of 25 to 75 years
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Intervention groups
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Intervention group containing: 2 Garlic tablets (each tablet contains 400 mg of garlic powder) twice a day after lunch and dinner, control group 2 placebo tablets each containing 400 mg of corn starch twice a day after lunch and dinner
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Main outcome variables
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Oxidative stress indices and inflammatory indices
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130903014551N11
Registration date:
2021-12-14, 1400/09/23
Registration timing:
prospective
Last update:
2022-01-09, 1400/10/19
Update count:
1
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Registration date
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2021-12-14, 1400/09/23
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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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2021-12-22, 1400/10/01
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Expected recruitment end date
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2022-09-23, 1401/07/01
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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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The effect of garlic supplementation on markers of inflammation and oxidative stress in patients with diabetic nephropathy
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Public title
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Garlic supplementation in patients with diabetic nephropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of diabetic nephropathy confirmed by a specialist
age 25-75 years old
being in the age range of 25 to 75 years clinically in stage 3 (eGFR equivalent to 30 to 59) or stage 4 (eGFR equivalent to 15 to 29) chronic kidney disease
Exclusion criteria:
not performing hemodialysis or peritoneal dialysis
presence of liver, gastrointestinal, stroke and ischemic heart disease (3 months after stroke and ischemic heart disease), pulmonary disease (asthma and COPD), cancer, hypothyroidism and hyperthyroidism, gastric ulcer, infectious especially hepatitis, garlic allergy
No pregnancy and lactation
not consuming drugs of anticoagulants such as heparin, warfarin, apixaban, uvaroxaban, penicillamine and 3 months after taking antibiotics
No history of taking garlic supplements and no special diet in the last 3 months
Not smoking
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Age
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From 25 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a valid random number generation website. (Random number generation website:https://www.sealedenvelope.com/simple-randomiser/v1/lists)
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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 are unaware of received intervention. Also, before beginning of intervention, garlic and placebo supplements, which are completely similar to each other, will be coded in A and B by a third person other than main researcher to keep the blinding of the study.
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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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2021-11-29, 1400/09/08
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.375
Health conditions studied
1
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Description of health condition studied
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Diabetic nephropathy
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ICD-10 code
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E11.2
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ICD-10 code description
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Type 2 diabetes mellitus with kidney complications
Primary outcomes
1
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Description
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Total antioxidant capacity (TAC)
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Timepoint
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Beginning of study - week 8
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Method of measurement
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Biochemical assessment
2
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Description
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Super oxide dismutase
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Timepoint
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Beginning of study - week 8
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Method of measurement
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Biochemical assessment
3
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Description
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Malon di aldehyde
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Timepoint
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Beginning of the study - week 8
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Method of measurement
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Biochemical assessment
4
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Description
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(CRP) C-reactive protein
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Timepoint
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Beginning of the study - week 8
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Method of measurement
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Biochemical assessment
Intervention groups
1
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Description
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Intervention group: Intervention group will receive 2 Garcin tablets made by Goldaru Isfahan Pharmaceutical Company each tablet containing 300 mg of garlic powder 1800-1200 micrograms of allicin and is equivalent to approximately 2 grams of fresh garlic twice a day after lunch and dinner for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: The Control group will received 2 placebo tablets made by Goldaru Isfahan Pharmaceutical Company each tablet containing 300 mg of cornstarch twice a day after lunch and dinner for 8 weeks.
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Category
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Placebo
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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Esfahan 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