Protocol summary

Study aim
Study of the effectiveness of sage on menopausal symptoms
Design
This study has been done on postmenopausal women that had some degree of menopausal symptoms.
Settings and conduct
This research has been done in Darab Health Center on postmenopausal women. The Menopausal Symptom Questionnaire was completed before and after received of sage extract
Participants/Inclusion and exclusion criteria
Entry condition: having menopausal symptoms and the exit condition: consumption of a special drug or other illness.
Intervention groups
This study has been done to evaluation of effectiveness of sage extract on menopausal symptoms in postmenopausal women.
Main outcome variables
Effectiveness of Sage in Reducing of Menopause Symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180130038557N1
Registration date: 2018-10-17, 1397/07/25
Registration timing: retrospective

Last update: 2018-10-17, 1397/07/25
Update count: 0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Fereshteh Dadfar
Name of organization / entity
Payame noor university
Country
Iran (Islamic Republic of)
Phone
+98 71 5356 4502
Email address
fereshtehdadfar2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interventional study on the effect of Sage (Saliva officinalis) extract on menopausal symptoms in postmenopausal women
Public title
Study of the effect of sage on menopause
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having menopause symptoms
Exclusion criteria:
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Research ethics committee of Payame Noor University
Street address
Mini city, Payame Noor University
City
Tehran
Province
Tehran
Postal code
19395-4697
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.PNU.REC.1397.024

Health conditions studied

1

Description of health condition studied
Menoapuse,Menopause symptoms
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
People with menopause symptoms
Timepoint
At the beginning of the study and one month after receiving the sage extract
Method of measurement
Menopausal Symptom Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Consumption of sage, A Salvigol tablet contains 100 mg of sage extract daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of Darab
Full name of responsible person
Fereshteh Dadfar
Street address
Enghelab Boulvard, Azadi Avenue
City
Darab
Province
Fars
Postal code
7481769945
Phone
+98 71 5356 4502
Email
fereshtehdadfar2003@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
دکتر حسین توللی
Street address
Saheli avenue
City
Shiraz
Province
Fars
Postal code
71893-73111
Phone
+98 71 3225 3161
Email
fereshtehdadfar2003@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor 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
Payame Noor University
Full name of responsible person
Fereshteh Dadfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Golestan avenue. Payame Noor University
City
Shiraz
Province
Fars
Postal code
71893-73111
Phone
+98 71 3622 2255
Email
fereshtehdadfar2003@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Fereshteh Dadfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Golestan avenue. Payame Noor University
City
Shiraz
Province
Fars
Postal code
71893-73111
Phone
+98 71362222255
Email
fereshtehdadfar2003@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Fereshte Dadfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Golestan avenue, Payame Noor University
City
Shiraz
Province
Fars
Postal code
71893-73111
Phone
+98 71362222255
Email
fereshtehdadfar2003@yahoo.com

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
Some of data
When the data will become available and for how long
6 months after printing of results
To whom data/document is available
University staff
Under which criteria data/document could be used
For research work
From where data/document is obtainable
email
What processes are involved for a request to access data/document
request by email
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