Objective: this study assesses the effect of Valeriana on the intensity and frequency of hot flashing Design: triple-blind randomized clinical trial that will be conducted on 64 menopauses between 45-55 years in health center of Shohada in Hamadan city. They will be randomly assigned to intervention and control groups with regard to Allocation concealment (32 in intervention group and 32 in control group). Setting and conduct: the eligible women with hot flashing complaint who refer to health center of Shohada in 2015 will be enrolled. Inclusion criteria: (a) age of between 45-55; (b) elapse of at least one and at most 5 years after menopausal (c) using cigarette and alcohol; (d) no having physical or mental diseases; (e) no using relaxation techniques (f) no using hormonal or herbal therapies Exclusion criteria: (a) drug intolerance (b) not complete treatment duration intervention: The treatment will be administered for capsule sedamin contain 530 milligram Valeriana twice in day for 2 months and in control group placebo will be prescribed similar to Valeriana for 2 months. Main outcome measures: the two groups will be compared in terms of the hot flash severity and frequency by Cooperman Index before the intervention, 1 month after the intervention and 2 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507206888N10
Registration date:2015-09-11, 1394/06/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-11, 1394/06/20
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-02-29, 1394/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical trial of valeriana and placebo comparison on severity and frequency of hot flash in menopausal women
Public title
The effect of Valeriana on severity and frequency hot flashes in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of between 45-55; elapse of at least one and at most 5 years after menopausal; no using cigarette and alcohol; no having physical or mental diseases; no using of relaxation techniques; no using of hormonal or herbal therapies
Exclusion criteria: drug intolerance; not complete treatment duration
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
UMSHA.REC.1394,7
Health conditions studied
1
Description of health condition studied
Hot flash
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Primary outcomes
1
Description
Hot flash severity
Timepoint
before the intervention, 1 month after intervention, 2 months after the intervention
Method of measurement
Cooperman Index
2
Description
hot flash frequency
Timepoint
before the intervention, 1 month after intervention, 2 months after the intervention
Method of measurement
Cooperman Index
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group: Sedamin will be prescribed in the form of Oral Capsule 530 mg, Twice in a day along two months. This drug Will be bought from Goldaroo Company in Iran.
Category
Treatment - Drugs
2
Description
In control group: placebo will be prescribed in the form of Oral Capsul contain 530 mg valeriana Twice in a day along two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Medical and Health Center
Full name of responsible person
Nahid Mohammadi, 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
Saied Bashirian
Street address
No. 307, Fahmideh Street, Hamadan University of Medical Sciences
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
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
+98 918 316 9936
Email
vc_research@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Ensiyeh jenabi
Position
Ph.D. student in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
+98 918 316 9936
Email
en.jenabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical Sciences
City
Hamadan
Postal code
65178
Phone
+98 81 3838 0150
Fax
+98 918 316 9936
Email
fshobeiri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)