Determining The effect of garlic supplementation on markers of inflammation and oxidative stress 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
Main outcome variables
Oxidative stress indices and inflammatory indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130903014551N11
Registration date:2021-12-14, 1400/09/23
Registration timing:prospective
Last update:2021-12-14, 1400/09/23
Update count:1
Registration date
2021-12-14, 1400/09/23
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic supplementation on markers of inflammation and oxidative stress 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
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
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
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.375
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
Total antioxidant capacity (TAC)
Timepoint
Beginning of study - week 8
Method of measurement
Biochemical assessment
2
Description
Super oxide dismutase
Timepoint
Beginning of study - week 8
Method of measurement
Biochemical assessment
3
Description
Malon di aldehyde
Timepoint
Beginning of the study - week 8
Method of measurement
Biochemical assessment
4
Description
(CRP) C-reactive protein
Timepoint
Beginning of the study - week 8
Method of measurement
Biochemical assessment
Secondary outcomes
empty
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrologist office Dr. Moinzadeh
Full name of responsible person
shohreh nikkhah
Street address
Unit 205, 2nd Floor, Farzin Building, Seyed Alikhan St., Ferdowsi St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3223 3886
Email
saraf2shr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
بهروز عطایی
Street address
Hezar-jerib Ave
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 56 1881 4521
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Faculty of Nutrition and Food Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
sm_rouhani@nutr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Faculty of Nutrition and Food Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
sm_rouhani@nutr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Faculty of Nutrition and Food Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
sm_rouhani@nutr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available