The effect of garlic tablets on metabolic syndrome in patients with poly cystic ovary syndrome(PCOS)
Design
A randomized, double-blind, placebo-controlled clinical trial with control group in parallel with a calculated sample size of 36 patients in each group totaling 72 patients.
Settings and conduct
Samples were selected from women referring to the infertility clinic of Arash Women General Hospital who met the inclusion criteria and were randomly assigned to one of two intervention or control groups. The intervention duration is 8 weeks and these patients will be evaluated at the beginning of the study and at the end of the eighth week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 15 to 49 years / unwilling to participate in the study / not pregnant / not having diabetes Mellitus / not having other chronic illnesses / not taking blood lipids and anticoagulants / minimal reading and writing literacy / Consume a maximum of one garlic per day
Exclusion criteria: unwillingness to continue participation / occurrence of any side effects caused by medication and intervention.
Intervention groups
Intervention group: Garlic tablets 500 mg twice daily for 8 weeks along with other medications such as Metformin
Control group: Garlic placebo in the same dose and form for 8 weeks.
Main outcome variables
Plasma Level of FBS/ Triglyceride/ HDL/Cholesterol total
Level of systolic and diastolic blood pressure
Waist-to-hip ratio and weight (WHR)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150905023897N4
Registration date:2019-11-09, 1398/08/18
Registration timing:registered_while_recruiting
Last update:2019-11-09, 1398/08/18
Update count:1
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
ِDr. Shahideh Jahanian Sadatmahalleh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4826
Email address
shahideh.jahanian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of garlic tablet on metabolic syndrome in PCOS patients : A Randomized Double-blind Placebo-controlled Trial
Public title
To evaluate the effect of garlic tablet on metabolic syndrome in PCOS patients : A Randomized Double-blind Placebo-controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People are willing to participate in the study
fertility age between 15-49 years
Iranian women
no pregnancy
have at least literacy for read and write
no Mellitus Diabets according to primary FBS
no chronic and coagulation disorders
lack of consumption Anti lipids and Anti hypertensive and anti coagulative drugs
no consuming garlic in a daily diet more than one cubit
Exclusion criteria:
People with drug side effects.Individuals unwilling to continue to participate in the study failure to comply with treatment protocol
Age
From 15 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups according to the blocking method and double blind
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and patient will be unaware of the treatment and grouping of the study. For this purpose, Garlic tablets and placebo are coded by a research center. The lead researcher treats patients in a double-blind manner based on the drug package code. The code for the drug package is recorded on the personal information form, and the researcher who completes the information form will not be informed of the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares university
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Approval date
2019-11-02, 1398/08/11
Ethics committee reference number
IR.MODARES.REC.1398.142
Health conditions studied
1
Description of health condition studied
Metabolic syndrome in PCOS patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
level of Triglyceride
Timepoint
First of study and 8 weeks after intervention
Method of measurement
blood biochemistry test
2
Description
level of cholesterol
Timepoint
First of study and 8 weeks after intervention
Method of measurement
blood biochemistry test
3
Description
blood level of HDL
Timepoint
First of study and 8 weeks after intervention
Method of measurement
blood biochemistry test
4
Description
blood level of FBS
Timepoint
First of study and 8 weeks after intervention
Method of measurement
blood biochemistry test
5
Description
level of systolic and diastolic blood pressure
Timepoint
First of study and 8 weeks after intervention
Method of measurement
Use of mercury barometer
6
Description
Waist to hip ratio
Timepoint
First of study and 8 weeks after intervention
Method of measurement
Use of meter
Secondary outcomes
1
Description
Level of CRP
Timepoint
First of study and 8 weeks after intervention
Method of measurement
Blood biochemistry test
2
Description
menstrual dysfunction such as: Oligomenorrhea and amenorrhea
Timepoint
First of study and 8 weeks after intervention
Method of measurement
patient statements
3
Description
clinical hyperandrogenemia
Timepoint
First of study and 8 weeks after intervention
Method of measurement
Blood biochemistry test and clinical symptom
4
Description
Ultrasound view of the ovaries
Timepoint
First of study and 8 weeks after intervention
Method of measurement
Use of ultrasound
5
Description
sexual function
Timepoint
First of study and 8 weeks after intervention
Method of measurement
FSFI questionnaire
6
Description
Quality Of life
Timepoint
First of study and 8 weeks after intervention
Method of measurement
MPCOSQ questionnaire
Intervention groups
1
Description
Intervention group: Treatment by garlic tab 500 mg
Category
Treatment - Drugs
2
Description
Control group: treatment by placebo of garlic tab
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Street address
Shahid baghdarnia Ave
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
hosp_arash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Street address
Jalal E AL Ahmad
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Phone
+98 21 8800 6544
Fax
+98 21 8800 6544
Email
pres@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares University
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
Tarbiat modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Phone
+98 21 2230 6480
Fax
+98 21 8288 4826
Email
Shahideh.jahanian@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Phone
+98 21 2230 6480
Fax
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shahideh Jahanian Sadatmahalleh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jalal E Al Ahmad
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۳۱۱۶
Phone
+98 21 2230 6480
Fax
+98 21 8288 4826
Email
shahideh.jahanian@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Information on the main outcome of the study
When the data will become available and for how long
1400
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Use for further research in the future
From where data/document is obtainable
Email Addressing Responsible for Study
What processes are involved for a request to access data/document