Objectives: The goal of this clinical trial study is to compare the effect of Cimifugol and Salvigol on menopausal symptoms (hot flashes, night sweating). Inclusion and criteria: Menopause women with at least one year after amenorrhea history that suffer from menopausal symptoms. Exclusion criteria: a history of malignancies in the past or right now; having active hepatic or renal disease; taking androgen, progesterone, HRT or other treatments to relief menopausal symptoms. Study population and sample size: 80 menopause women from Hamadan. Intervention: After explaining goal of the study to participants and obtaining informed consent, information about menopause will be recorded and Green's menopausal index will be used to assess the severity of menopausal symptoms. Samples will be divided randomly in two groups; one will take Cimifugol and another one Salvigol Balance for 8 weeks. At the end of every week, we will call samples to make sure of using drugs. Green's menopausal index will be completed again at the end of 4th and 8th weeks, and two groups will be compared. Findings will be analyzed by SPSS software. Primary outcomes: Relieving menopausal symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070723640N5
Registration date:2016-09-04, 1395/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Farzaneh Soltani
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 813220683
Email address
soltani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Hamadan University of Medical sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evalution of Cimifugol and Salvigol effect on hot flash ,night sweating in menopausal women
Public title
Comparative evalution of Cimifugol and Salvigol effect on hot flash ,night sweating in menopausal women attending to Hamadan health care centers in 2016
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least one year after the last amenorrhea; lack of acute and chronic diseases with the approval of physician; not taking any herbal remedy from 3 months before the intervention; no previous allergy to herbal drugs. Exclusion criteria: having breast and genital cancer or a history of having them in the past; experiencing acute and chronic diseases during the study; lack of proper use of drugs during the study; medical allergy.
Age
From 40 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
City
Hamadan
Postal code
65178/518
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.UMSHA.REC.1394.532
Health conditions studied
1
Description of health condition studied
Symptoms of Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Hot flash
Timepoint
before intervention- 4 weeks later- 8 weeks later
Method of measurement
Scale Greene
2
Description
night sweating
Timepoint
before intervention- 4 weeks later- 8 weeks later
Method of measurement
Scale Greene
Secondary outcomes
1
Description
side effects
Timepoint
End of every week by calling.
Method of measurement
End of every week by calling.
Intervention groups
1
Description
firct group: They will use oral tablet Cimi fugol daily for 8 weeks ,one tablet after dinner.
Category
Treatment - Drugs
2
Description
second group: Salvia officinalis extract, 100 mg tablet, three times daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Medical and Health Center
Full name of responsible person
Roya Ahmadi Niyatabesh, M.Sc. of Health, Instructor
Street address
No. 11, Takhti Street, Shohada Medical and Health Center, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian Saeed
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Roya Ahmadi Niyatabesh
Position
Student Counseling in Midwifery
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 3838 0150
Fax
Email
niyatabesh90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farzaneh Soltani
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Fahmiheh Street, Hamadan University of Medical Sciences
City
Hamadan
Postal code
6513868917
Phone
+98 81 3838 0319
Fax
Email
farzanehsoltani2008@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fahmideh Street, Hamadan Universiy of Medical Sciences
Full name of responsible person
Farzaneh Soltani
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Hamadan University of Medical sciences
City
Hamadan
Postal code
6516645977
Phone
+98 81 3827 6051
Fax
Email
farzanehsoltani2008@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)