The aim of this triple blind randomized placebo controlled trial, is to investigate effect of Salvia officinalis on hot flush and sweating in menopausal women who refer to clinic by this complains. Participants consist of 84 women by this inclusion criteria: menopause age 45-60,at least 12 month since last menstruation, no serious illnesses, no use of HRT, BMI below29, no stress at least during last month. no allergy to herb or plants, normal diet, no smoking or addiction. Exclusion criteria include the use of medication with influence on menopausal symptoms, allergy to Sage or not using Sage. They randomly divide into group A (will receive one A capsule daily) and group B (will receive one B capsule daily). At first participants will be asked to fill some forms about their hot flush, the severity, duration and frequency of their hot flush and severity and frequency of sweating in one week before intervention. Then they will receive one oral capsule (100mg) Sage or placebo in 8 weeks and continue filling the forms every week. The data before and after intervention will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070410182N1
Registration date:2013-01-03, 1391/10/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-03, 1391/10/14
Registrant information
Name
Homa Sadeghi Avval Shahr
Name of organization / entity
Tehran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
ho-sadeghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-08-28, 1391/06/07
Expected recruitment end date
2012-11-04, 1391/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Salvia officinalis on hot flush and sweat in menopausal women
Public title
Effects of Sage on hot flush and sweat in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age45-60 (in 60 years we include women that maximum 5 year); married; by history of maternity; at least 12 month since last menstruation; ability to read and write; at least 3 hot flushes daily; no serious illnesses; no smoking or addict; no use of HRT; BMI<29; no stress at least 1 month; normal food; no allergy to herb or plants.
Exclusion criteria: no inclination for using of drug; no filling the forms; use of medication with an influence on menopausal symptoms; in stress or use of special food diet; allergy to drug.
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:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Faculty of Nursing and Midwifery
Street address
Faculty of Nursing and Midwifery, Tohid square, Tehran
City
Tehran
Postal code
1419733171
Approval date
2012-07-29, 1391/05/08
Ethics committee reference number
907/130/د/91
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
Hotflush
Timepoint
1 week before intervention, 8 week after intervention
Method of measurement
questionnaire
2
Description
Sweat
Timepoint
1 week before intervention, 8 week after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Extract of Salvia officinalis- Capsul 100 mg- Oral- Daily- 8 week
Category
Treatment - Drugs
2
Description
Placebo- Capsul 100 mgr- Daily- 8 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lahijan number 1 the health and curative center
Full name of responsible person
Mahnaz Bakhshi, Studend of Msc in Midwifery
Street address
Lahijan number 1 the health and curative center, 22 aban street, Lahijan
City
Lahijan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Homa Sadeghi, Msc in midwifery
Street address
Faculty of Nursing and Midwifery, Tohid Square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Bakhshi
Position
Student of Msc of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tohid Square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
m_bakhshi49@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Homa Sadeghi
Position
Msc in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tohid Square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
ho-sadeghi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Homa Sadeghi
Position
Msc in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tohid square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
ho-sadeghi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)