Protocol summary

Summary
Among 46 patients undergoing peritoneal dialysis who refered to Shafa Dialysis Center, according to inclusion & exclusion criteria, 40 eligible patients were chosen. The paitients participated in the study consciosly and arbitrarily and they were chosen with respect to ethics confirmed by the hospital ethic commettee and were enrolled in RCT Bank. The qualified patients were divided into intervention and control groups (each group consisted of 20 people) according to balanced block randomization method. In intervention group, in addition to the standard treatment, patients received 400 mg of standard garlic powder extract tablets twice a day for 8 weeks. each tablet contains 1000 micrograms of alliin. In the control group, a placebo was prescribed during this period. Lipid profile ,inflammatory and cardiovascular indicators and peritoneal function tests were evaluated in each group before and after intervention. Patients were monitored for any complications, side effects and drug safety in each follow up visits. Anonymously collected demographic data includes age, sex,history of diabetes, history of hypertension, lipid profile, underlying disorders leading to renal failure, duration of the disease, duration of peritoneal dialysis, drug history and inflammatory and cardiovascular indicators. Statistical analysis will be performed by SPSS 19 software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072535305N1
Registration date: 2017-10-16, 1396/07/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
Amirhesam Alirezaei
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3095
Email address
aalirezaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Modarres Hospital Clinical Research Center,Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral administration of Allium sativum on lipid profile,inflammatory indexes, function and structure of peritoneal membrane in patients on peritoneal dialysis
Public title
Efficacy of oral administration of Allium sativum on lipid profile,inflammatory indexes, function and structure of peritoneal membrane in patients on peritoneal dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria : Recent use of medicines and foods that contain garlic; sensitivity to garlic; history of bleeding; disorders and use of warfarin; history of infection or hospitalization inthe last 3 months; unwillingness to continue to participate in the research project; history of gastric bypass; do not use more than 80% of medicine. Inclusion criteria : age above 18; six months have passed since the onset of peritoneal dialysis.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid modarres hospital
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.SBMU.MSP.REC.1396.114

Health conditions studied

1

Description of health condition studied
Z49.2
ICD-10 code
Z49.2
ICD-10 code description
Other dialysis

Primary outcomes

1

Description
Lipid profil,TG.CHOL.HDL.LDL in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

2

Description
IL6 in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

3

Description
ESR in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

4

Description
Albumin in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

5

Description
CRP in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

6

Description
Ferritin in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

7

Description
Homocysteine in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

8

Description
CBC.diff in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

9

Description
Serum iron in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

10

Description
Peritoneal equilibration test in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

11

Description
Blood pressure in control group
Timepoint
Before and after intervention
Method of measurement
Sphygmomanometer

12

Description
Weight in control group
Timepoint
Before and after intervention
Method of measurement
Scale

13

Description
ASt in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

14

Description
ALT in control group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

15

Description
Lipid profil,TG.CHOL.HDL.LDL
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

16

Description
IL6 in case group in cases group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

17

Description
ESR in cas3 group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

18

Description
Albumin in case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

19

Description
CRP in case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

20

Description
Ferritin Fein case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

21

Description
Homocysteine in case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

22

Description
CBC.diff in case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

23

Description
Serum iron in case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

24

Description
Peritoneal equilibration test in case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

25

Description
Blood pressure Blin case group
Timepoint
Before and after intervention
Method of measurement
Sphygmomanometer

26

Description
Weight in case group
Timepoint
Before and after intervention
Method of measurement
Scale

27

Description
AST in case group
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

28

Description
ALT in case gruop
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, patients received 400 mg of standard garlic powder extract tablets twice aday for 8 weeks. each tablet contains 1000 micrograms of alliin. The drug was produced by the Amin pharmaceutical company.
Category
Treatment - Drugs

2

Description
In the control group, The placebo was prescribed.The placebo was completely similar to the original drug and it was made of starch.and it also The drug was produced by the Amin pharmaceutical company.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafaa Dialysis Center
Full name of responsible person
Amirhesam Alirezaei
Street address
Shafaa Dialysis Center, Farhang hosseini street, Taleghani, Valiasr street , Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Modarres Clinical Research Center,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirhesam alirezaei
Street address
Shahid Modarres Hospital,Sa'adat abad,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Modarres Clinical Research Center,Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirhesam Alirezaei
Position
Nephrologist
Other areas of specialty/work
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-6311
City
Tehran
Postal code
Phone
+98 21 2208 3112
Fax
Email
Amirhesam124@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Modarres Hospital,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirhesam Alirezaie
Position
Nephrologist
Other areas of specialty/work
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-6311
City
Tehran
Postal code
Phone
+98 21 2208 3095
Fax
Email
amirhesam124@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshtu University Of Medical Scienses
Full name of responsible person
Amirhesam Alirezaei
Position
Nephrologist
Other areas of specialty/work
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Post Code: 19839-6311
City
Tehran
Postal code
Phone
+98 21 2208 3112
Fax
Email
Amirhesam124@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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