This study aims to investigate the influence of Salvia tablets on hot flashes, night sweats and the estradiol hormone in postmenopausal women who refer to health Care centers in Shiraz in 1393. This study is based on a double-blind randomized clinical trial performed on 100 postmenopausal women with hot flashes who qualified for the study. The population of eligible women is divided into two groups, A and B, each of which consists of 50 patients using Randomized block permutation. Members of group A take medicine A and members of group B take medicine B. Women are well aware that they are divided randomly. The researcher make questionnaire including demographic information and Menopause Rating Scale (MRS) which will be answered by the researcher. The level of concentration of samples of plasma estradiol hormone are controlled. Women are asked to complete the questionnaire , the first week before intervention that includes the number, severity and duration of hot flashes and the number and severity of night sweats. Then they receive three oral tablet (100mg) Sage or placebo per day for 8 weeks and continue filling the forms every week. .At the end of 8 weeks, menopause rating scale questionnaire will be completed by researcher and Estradiol tests will be repeated. The data before and after the intervention will be compared and statically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062218187N1
Registration date:2014-07-22, 1393/04/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-22, 1393/04/31
Registrant information
Name
Sedighe Forouhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 987136474257
Email address
foruharis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Salvia officinalis Tablet on hot flash, night sweating and estradiol hormone in postmenopausal women
Public title
The effect of Salvia officinalis on hot flush and night sweat in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women between 45 to 60 years old who are less than 5 years after menopause; At least 12 months since last menstruation; At least three hot flushes daily; Written informed consent; No known physical or mental illness; Not using any medication with influence on menopausal symptoms within three month before the study start; BMI less than 29; No history of allergy to herbal medicine; No smoking or addiction; No use of medication with influence on menopausal symptoms.
Exclusion criteria:Use of medication with influence on menopausal symptoms; Allergy to the medicine used or not used in the study; Patient reluctance
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:
100
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
Ethics Committee, Shiraz University of Medical Sciences
Street address
Research Deputy, Shiraz University of Medical Science
City
shiraz
Postal code
1978-71345
Approval date
2014-03-19, 1392/12/28
Ethics committee reference number
92-6942
Health conditions studied
1
Description of health condition studied
Menopausal and femal climacteric state
ICD-10 code
N95.1
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
hot flash
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Questionnaire
2
Description
Night sweats
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Questionnaire
3
Description
Estradiol
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Laboratory pg per ml
Secondary outcomes
1
Description
Menopausal Symptoms
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Menopause Rating Scale questionnaire
Intervention groups
1
Description
Salvia officinalis extract, 100 mg tablet, three times daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Placebo, tablets 100 mg, three times daily, 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic in Shiraz
Full name of responsible person
Sima Gichlou, Studend of Msc in Midwifery
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed basir hashemi
Street address
Technology and Research Office, Research Deputy , Shiraz University of Medical Science, Zand Street, Shiraz
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
shiraz
Postal code
71345-1978
Phone
+98 71 1647 4257
Fax
+98 71 1647 4252
Email
forouharism@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
shiraz
Postal code
71345-1978
Phone
+98 71 1647 4257
Fax
+98 71 1647 4252
Email
foruharis@sums.ac
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
shiraz
Postal code
Phone
+98 71 1647 4257
Fax
+98 71 1647 4252
Email
forouharism@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)