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General information
empty
Changing the dose of the drug, placebo and the name of the company producing the drug and placebo used in the intervention group
Changing the dose of the drug, placebo and the name of the company producing the drug and placebo used in the intervention group
empty
به دلیل تغییر دوز دارو، دارونما و اسم شرکت تولید کننده دارو و دارونما مصرفی در گروه مداخله
به دلیل تغییر دوز دارو، دارونما و اسم شرکت تولید کننده دارو و دارونما مصرفی در گروه مداخله
Intervention groups
#1
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
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
Intervention group: Intervention group will receive 2 GarlicGarcin tablets made by AminGoldaru Isfahan Pharmaceutical Company each tablet containing 400300 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
گروه مداخله:گروه مداخله یا دریافت کننده مکمل، 2 عدد قرص گارلیک ساخت شرکت داروسازی امین اصفهان هر قرص شامل 400 میلی گرم پودر سیر خشک شده محتوی 1800-1200 میکروگرم آلیسین و معادل تقریبا دو گرم سیر تازه است و به صورت دو بار در روز بعد از ناهار و شام به مدت 8 هفته دریافت خواهند کرد
گروه مداخله:گروه مداخله یا دریافت کننده مکمل، 2 عدد قرص گارسین ساخت شرکت داروسازی گل دارو اصفهان هر قرص شامل 300 میلی گرم پودر سیر خشک شده محتوی 1800-1200 میکروگرم آلیسین و معادل تقریبا دو گرم سیر تازه است و به صورت دو بار در روز بعد از ناهار و شام به مدت 8 هفته دریافت خواهند کرد
گروه مداخله:گروه مداخله یا دریافت کننده مکمل، 2 عدد قرص گارلیکگارسین ساخت شرکت داروسازی امینگل دارو اصفهان هر قرص شامل 400300 میلی گرم پودر سیر خشک شده محتوی 1800-1200 میکروگرم آلیسین و معادل تقریبا دو گرم سیر تازه است و به صورت دو بار در روز بعد از ناهار و شام به مدت 8 هفته دریافت خواهند کرد
#2
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.
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.
Control group: The Control group will received 2 placebo tablets made by AminGoldaru Isfahan Pharmaceutical Company each tablet containing 400300 mg of cornstarch twice a day after lunch and dinner for 8 weeks.
گروه کنترل: 2عدد قرص دارونما ساخت شرکت داروسازی امین اصفهان هر قرص حاوی 400 میلی گرم نشاسته ذرت و به صورت دوبار در روز بعد از ناهار و شام به مدت 8 هفته دریافت خواهند کرد.
گروه کنترل: 2عدد قرص دارونما ساخت شرکت داروسازی گل دارو اصفهان هر قرص حاوی 300 میلی گرم نشاسته ذرت و به صورت دوبار در روز بعد از ناهار و شام به مدت 8 هفته دریافت خواهند کرد.
گروه کنترل: 2عدد قرص دارونما ساخت شرکت داروسازی امینگل دارو اصفهان هر قرص حاوی 400300 میلی گرم نشاسته ذرت و به صورت دوبار در روز بعد از ناهار و شام به مدت 8 هفته دریافت خواهند کرد.
Recruitment centers
#1
Name of recruitment center - English: Office of a nephrologist Dr. Moinzadeh
Name of recruitment center - Persian: مطب متخصص نفرولوژیست خانم دکتر معین زاده
Full name of responsible person - English: shohreh nikkhah
Full name of responsible person - Persian: شهره نیکخواه
Street address - English: Isfahan, Ferdowsi St., Seyed Alikhan St., Farzin Building, 2nd Floor, Unit 205
Street address - Persian: اصفهان، خیابان فردوسی، خیابان سید علیخان، ساختمان فرزین، طبقه 2، واحد ۲۰۵
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 3223 3886
Fax:
Email: saraf2shr@yahoo.com
Web page address:
Name of recruitment center - English: Nephrologist office Dr. Moinzadeh
Name of recruitment center - Persian: مطب متخصص نفرولوژیست خانم دکتر معین زاده
Full name of responsible person - English: Shohreh Nikkhah
Full name of responsible person - Persian: شهره نیکخواه
Street address - English: Unit 205, 2nd Floor, Farzin Building, Seyed Alikhan St., Ferdowsi St.
Street address - Persian: خیابان فردوسی، خیابان سید علیخان، ساختمان فرزین، طبقه 2، واحد ۲۰۵
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81746-73461
Phone: +98 31 3223 3886
Fax:
Email: saraf2shr@yahoo.com
Web page address:
Name of recruitment center - English: Office of a nephrologistNephrologist office Dr. Moinzadeh Name of recruitment center - Persian: مطب متخصص نفرولوژیست خانم دکتر معین زاده Full name of responsible person - English: shohreh nikkhahShohreh Nikkhah Full name of responsible person - Persian: شهره نیکخواه Street address - English: IsfahanUnit 205, Ferdowsi St.2nd Floor, Farzin Building, Seyed Alikhan St., Farzin Building, 2nd Floor, Unit 205Ferdowsi St. Street address - Persian: اصفهان، خیابان فردوسی، خیابان سید علیخان، ساختمان فرزین، طبقه 2، واحد ۲۰۵ City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81746-73461 Phone: +98 31 3223 3886 Fax: Email: saraf2shr@yahoo.com Web page address:
Protocol summary
Study aim
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
Changing the dose of the drug, placebo and the name of the company producing the drug and placebo used in the intervention group
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20171107037302N3
Registration date:2021-11-27, 1400/09/06
Registration timing:prospective
Last update:2022-01-11, 1400/10/21
Update count:1
Registration date
2021-11-27, 1400/09/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3434 3834
Email address
s.sarafbank@nutr.mui.ac.ir
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 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 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
Category
Treatment - Drugs
2
Description
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.
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
Isfahan
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
Behruz Ataei
Street address
Hezar-jerib Ave
City
Isfahan
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
Sahar Saraf-Bank
Position
Assistant Professeor
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
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3127
Email
saraf2shr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar Saraf-Bank
Position
Assistant Professsor
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
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
saraf2shr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar Saraf-Bank
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
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
saraf2shr@yahoo.com
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