Determining the effect of garlic supplementation on risk factors for cardiovascular disease and renal function in patients with diabetic nephropathy
Design
randomized clinical trial, double-blind, randomized control group of 60 patient. Randomization is done using a valid website and a 4-block method.
Settings and conduct
This clinical trial study will be performed in the office of a nephrologist. Researchers, participants will be unaware of the allocation of treatments.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
The effect of garlic supplementation on risk factors for cardiovascular disease and renal function in patients with diabetic nephropathy
Public title
Garlic supplementation in patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetic nephropathy confirmed by a specialist - - 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
age 25-75 years old
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
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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)
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Vice Chancellor in Research Affairs-medical university of Isfahan
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-11-15, 1400/08/24
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.342
Health conditions studied
1
Description of health condition studied
Diabetic nephropathy
ICD-10 code
E11.2
ICD-10 code description
Type 2 diabetes mellitus with kidney complications
Primary outcomes
1
Description
weight
Timepoint
Beginning of study - week 8
Method of measurement
Digital scales
2
Description
Waist circumference
Timepoint
Beginning of study - week 8
Method of measurement
strip meter
3
Description
Body mass index
Timepoint
Beginning of study - week 8
Method of measurement
formula
4
Description
Mild arm circumference
Timepoint
Beginning of study - week 8
Method of measurement
stripe meter
5
Description
Fasting blood sugar
Timepoint
Beginning of study - week 8
Method of measurement
biochemical assesment
6
Description
triglycerides
Timepoint
Beginning of study - week 8
Method of measurement
biochemical assessment
7
Description
low density lipoprotein- cholesrtol
Timepoint
Beginning of study - week 8
Method of measurement
formula
8
Description
high density lipoprotein-cholestrol
Timepoint
Beginning of study - week 8
Method of measurement
biochemical assessment
9
Description
Total cholestrol
Timepoint
Beginning of study - week 8
Method of measurement
biochemical assessment
10
Description
Fasting insulin
Timepoint
Beginning of study - week 8
Method of measurement
biochemical assessment
Secondary outcomes
1
Description
Estimated glomerular filtration rate
Timepoint
Beginning of the study - week 8
Method of measurement
Formula
2
Description
Blood urea nitrogen
Timepoint
Beginning of the study - week 8
Method of measurement
Biochemical assessment
3
Description
creatinine
Timepoint
Beginning of the study - week 8
Method of measurement
Biochemical assessment
Intervention groups
1
Description
Intervention group: Intervention group will receive 2 Garlic tablets made by Amin Isfahan Pharmaceutical Company each tablet containing 400 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
Category
Treatment - Drugs
2
Description
Control group: The Control group will received 2 placebo tablets made by Amin Isfahan Pharmaceutical Company each tablet containing 400 mg of cornstarch twice a day after lunch and dinner for 8 weeks.