Determining the effect of garlic extract on the level of inflammatory factors in hemodialysis patients of the Dialysis Center of Bu Ali Sina Hospital of Qazvin in 1399
Design
Then patients were randomly selected using allocation random software
Settings and conduct
At first, in this double-blind clinical trial study, 54 eligible kidney failure patients referred to the dialysis center of Bu Ali Sina Hospital are checked.
Patients registered in the form of a questionnaire. These patients are also undergoing blood sampling during routine monthly blood sampling by a dialysis nurse for tests.
Sampling is done at 22 ccs when they are fasting, then samples are sent to a laboratory.
Patients are randomly selected using allocation random software.
Software is assigned in two groups (at the end of the proposal). Then garlic tablet is given to group A and placebo is given to group B. After two months, re-sampling is done to measure the intended factors. During the study, taking pills is followed by the facilitator by counting the pills and calling them.
Participants/Inclusion and exclusion criteria
Entry criteria:
All patients with chronic renal failure related to hemodialysis.
Having consented to participate in the project.
Exclusion criteria:
Patients with sensitivity to garlic.
Existence of autoimmune diseases such as rheumatic diseases and chronic inflammatory diseases.
History of corticosteroid use Anticoagulants.
Patients with a history of glomerulonephritis as a cause of chronic renal failure.
Intervention groups
Hemodialysis patients
Main outcome variables
IL6 -ESR- CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200831048562N1
Registration date:2021-03-15, 1399/12/25
Registration timing:registered_while_recruiting
Last update:2021-03-15, 1399/12/25
Update count:0
Registration date
2021-03-15, 1399/12/25
Registrant information
Name
Freshteh Khanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 4264
Email address
f.khanzadeh7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Garlic tablet effects on Hemodialysis patients Inflammatory factors.
Public title
Evaluating the effect of Garlic on dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All ESRD patients who need hemodialysis (at least six months before dialysis starts)
Exclusion criteria:
Allergic to garlic patients
Corticosteroids, Anticoagulants, and Statins using records
Underlying autoimmune disease records on patients
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two treatment groups A and B using the balance block randomization method, the size of each block is 6 and the block quantity is 10.
The method of balanced randomization allocation is used for participants in a randomized controlled clinical trial study to evaluate the effect of garlic tablets (group A) and placebo (group B) on quantitative variables (IL4 -ESR-CRP-BMI, calcium, phosphorus, Albumin, LDL-HDL-K-Na) is used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The double-blind method is used for this study. The patients who have been studied are located in two groups of "intervention" & "control". The researcher and patient are blind regarding drugs and placebo usage.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Minudar Street, Velaiat Hospital
City
Qazvin
Province
Qazvin
Postal code
3415755570
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.QUMS.REC.1399.145
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
CRP
Timepoint
At the beginning of the study and two months after intervention
Method of measurement
serum sample
2
Description
ESR
Timepoint
At the beginning of the study and two months after intervention
Method of measurement
serum sample
3
Description
IL6
Timepoint
At the beginning of the study and two months after intervention
Method of measurement
serum sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A is given garlic tablets twice a day for two months
Category
Treatment - Drugs
2
Description
Control group: Group B placebo (without color and taste) is given twice a day for two months