Evaluation effect of garlic supplementation tablet on dialysis adequacy and serum albumin, PTH, calcium, phosphorus and CRP levels and blood lipid profile in patients undergoing chronic hemodialysis
Design
Randomized controlled clinical trial with parallel groups, triple-blind, of 88 patients. Random allocation software is used for randomization.
Settings and conduct
This study was performed in chronic kidney patients treated with hemodialysis in Khorshid and Amin hospitals in Isfahan.The main researcher, all colleagues involved in data collection, laboratory and analyzer and the safety and monitoring committee are not aware of the assignment of subjects to the two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age > 18 years,patients with chronic hemodialysis for at least three months And consent to to participate in the study
Exclusion criteria: Patients receiving warfarin, clopidogrel and being pregnant
Intervention groups
Intervention group: 44 participants will take an odorless garlic supplement for 8 weeks, which contains 500 mg of garlic powder and 2 mg allicin at each tablet (manufactured by Gol Daroo Company), two tablets daily ,after lunch.
Control group: 44 participants will take placebo tablets containing starch and odorless (made by Gol Daroo company) for 8 weeks, two tablets daily, after lunch.
Main outcome variables
Dialysis adequacy; Serum albumin level; PTH level; calcium level; phosphorus level; CRP level; blood lipid profile in all participants (n = 88)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210825052286N1
Registration date:2021-10-17, 1400/07/25
Registration timing:prospective
Last update:2021-10-17, 1400/07/25
Update count:0
Registration date
2021-10-17, 1400/07/25
Registrant information
Name
farzaneh fatahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 6177
Email address
drfatahi79@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of garlic supplementation pill on dialysis adequacy , serum albumin, PTH, calcium, phosphorus, CRP levels and blood lipid profile in patients undergoing chronic hemodialysis in Khorshid and amin hospital (Esfahan)2020-2021
Public title
Effect of garlic supplementation pill in dialyisic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic kidney Patients that undergoing hemodialysis for at least three months
Exclusion criteria:
Patients receiving warfarin, clopidogrel
Being pregnant
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
After collecting all the subjects (88 patients), they are divided into two groups of intervention (44 patients) and control (44 patients) by simple individual randomization using statistical software.In this process participants, researchers and questioners, sample takers and registrants, data importers and data analysts, as well as the Data Monitoring and Safety Committee are unaware of the type of this allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the assignment stage : All subjects are divided into two intervention and control groups of 44 people without any knowledge in terms of allocation as well as questioners.
In the blood sampling stage at pre- and post-intervention phase, the participant ,samplers, laboratory staff, questioners, and registrants of the results are not aware of the participants' assigned group.
In the intervention stage: the intervention group is given a garlic supplement that is odorless and the control group is given control of placebo tablets containing starch that are odorless and have the same appearance as garlic tablets (from the same company).
In the stage of data collection and analysis: Questioners, data importers and analysts do not know the type of intervention and control group and the data is given to them in form of group 1 and group 2.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jerib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-16, 1400/04/25
Ethics committee reference number
IR.MUI.MED.REC.1400.319
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
serum albumin
Timepoint
before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum albumin
2
Description
Serum PTH(Para Thyroid Hormone)
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
blood sampling for serum PTH
3
Description
Serum calcium
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum calcium
4
Description
Serum phosphorus
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum phosphorus
5
Description
serum CRP(C-Reactive Peptide)
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum CRP(C-Reactive Peptide)
6
Description
Serum total cholesterol
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum total cholesterol
7
Description
Serum Low Density Lipoprotein (LDL)
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum Low Density Lipoprotein (LDL)
8
Description
Serum High Density Lipoprotein (HDL)
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum High Density Lipoprotein (HDL)
9
Description
Serum triglyceride
Timepoint
Before intervention and 8 weeks after intervention starts
Method of measurement
Blood sampling for serum triglyceride
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Garlic pill made by Gol Daroo Pharmaceutical Company, which is odorless and contains 500 mg of garlic t and 2 mg of allicin, two pills daily after lunch.
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets of Gol Daroo Pharmaceutical Company that contain starch and they are odorless and have the same appearance as garlic pills, two pills daily after lunch
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Sahar Vahdat
Street address
No 105 ,Ostandari Ave, Khorshid Hospital
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Sahar Vahdat
Street address
AVE SINA Ave
City
ESFAHAN
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar -Jerib Ave
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.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
Farzaneh Fatahi
Position
Assisstant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 100, Farshadi Ave,Chahar Bagh Bala Ave
City
Esfahan
Province
Isfehan
Postal code
8175963681
Phone
+98 31 3625 6177
Email
drfatahi79@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzaneh Fatahi
Position
Assisstant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
NO. 100,Farshadi Ave,Chahar Bagh Bala Ave
City
Esfahan
Province
Isfehan
Postal code
8175963681
Phone
+98 31 3625 6177
Email
drfatahi79@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzaneh Fatahi
Position
assisstant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No 100,Farshadi Ave, Chahar Bagh Bala Ave
City
Esfahan
Province
Isfehan
Postal code
8175963681
Phone
+98 31 3625 6177
Email
drfatahi79@gmail.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