Protocol summary

Study aim
The effect of boiled garlic and Shirazi lemon on blood lipids in hyperlipidemia patients
Design
Before and after clinical trial Twenty-eight patients with hyperlipidemia in one group
Settings and conduct
This study will be conducted on patients with hyperlipidemia in Gonabad, Iran. The intervention includes 30 cc boiled garlic and lemon which will be taken by the patients in each meal for 3 weeks. Then, after one week wash-out period, the intervention will be repeated. Measuring blood lipids will be done before intervention, three weeks after the intervention, and at the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Over 18 years old 2- with hyperlipidemia 3- Resident of Gonabad 4- Willing to participate in the study Exclusion criteria: 1- Peptic ulcer 2- Indigestion 3- Gastrointestinal inflammatory diseases 4- Sensitivity to boiled garlic and lemon 5- Having Other chronic diseases
Intervention groups
Thirty cc boiled garlic and lemon will be taken by the patients in each meal for 3 weeks. Then, after one week wash-out period, the intervention will be repeated.
Main outcome variables
Cholesterol; triglyceride; LDL; HDL

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190317043076N1
Registration date: 2019-07-13, 1398/04/22
Registration timing: retrospective

Last update: 2019-07-13, 1398/04/22
Update count: 0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Hosein َAjamzibad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
ajam.h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
2014-04-21, 1393/02/01
Actual recruitment end date
2014-11-21, 1393/08/30
Trial completion date
2015-01-20, 1393/10/30
Scientific title
The effect of boiled garlic and Shirazi lemon on blood lipids in hyperlipidemic patients
Public title
The effect of boiled garlic and lemon on blood lipids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in the study Resident of Gonabad Having hyperlipidemia Over 18 years old
Exclusion criteria:
Peptic ulcer Indigestion Gastrointestinal inflammatory diseases Sensitivity to boiled garlic and lemon Having other chronic diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
Actual sample size reached: 28
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Next to the Asian Road, Deputy for Research, Gonabad University of Medical Sciences, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Approval date
2014-03-12, 1392/12/21
Ethics committee reference number
GMU.REC.1392.81

Health conditions studied

1

Description of health condition studied
Hyperglycemia
ICD-10 code
E78.2
ICD-10 code description
Mixed hyperlipidemia

Primary outcomes

1

Description
Level of blood cholesterol
Timepoint
Before intervention; three weeks after the intervention, and at the end of the intervention
Method of measurement
Autoanalyser: BT3000 PLUS

2

Description
Level of blood triglyceride
Timepoint
Before intervention; three weeks after the intervention, and at the end of the intervention
Method of measurement
Autoanalyser: BT3000 PLUS

3

Description
Level of blood LDL
Timepoint
Before intervention; three weeks after the intervention, and at the end of the intervention
Method of measurement
Autoanalyser: BT3000 PLUS

4

Description
Level of blood LDL
Timepoint
Before intervention; three weeks after the intervention, and at the end of the intervention
Method of measurement
Autoanalyser: BT3000 PLUS

Secondary outcomes

empty

Intervention groups

1

Description
Thirty cc boiled garlic and lemon will be taken by the patients in each meal for 3 weeks. Then, after one week wash-out period, the intervention will be repeated.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman hospital
Full name of responsible person
Hadi Sajjadi
Street address
Naserkhosro
City
Gonabad
Province
Razavi Khorasan
Postal code
9691844177
Phone
+98 51 5722 9012
Email
info@gmu.ac.ir
Web page address
http://www.gmu.ac.ir/Index.aspx?tempname=BimarestanBohlool&lang=1&sub=0&epageId=480810

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3401
Fax
+98 51 5722 3401
Email
khosravan@gmu.ac.ir
Web page address
http://res.gmu.ac.ir/Index.aspx?page_=form&lang=1&sub=21&tempname=research&PageID=484607
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Tahere Baloochi Beydokhti
Position
Faculty member (Instructor)
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3028
Email
tbaloochi@gmail.com
Web page address
https://scholar.google.com/citations?user=BSeLIq4AAAAJ&hl=en&oi=ao

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hosein Ajamzibad
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3028
Email
ajam.h@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hosein Ajamzibad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3028
Email
ajam.h@gmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data file does not add any information to science.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The entire data is potentially shared after being coded.
When the data will become available and for how long
Access onset will be 6 months after the publication of results.
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
No limitation.
From where data/document is obtainable
Gonabad University of Medical Sciences
What processes are involved for a request to access data/document
Applying to the deputy of research at Gonabad University of Medical Sciences and following the legal procedure
Comments
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