Comparative of the effect of combination of black Kohush - soybean and Primerose oil versus placebo on hot flash and night sweating in menopausal women: a double blind randomized clinical trial
To assess the effect of combination of black Kohush - soybean and Primerose oil versus placebo on hot flash and night sweating in menopausal women
Design
This a double-blind randomized clinical trial, phase II, in which 120 eligible menopausal women will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible menopausal women who will refer to Health Centers in Hamadan City during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 45 to 80 years
Menopause
Exclusion criteria:
Any acute or chronic disease
Using any herbal drug during the past e months
Hypersensitivity to medicinal pants
Intervention groups
Intervention group 1: Oral using a combination of black Kohush - soybean twice a day for 8 weeks
Intervention group 2: Using Primerose oil capsule twice a day for 8 weeks
Control group: Using placebo twice a day for 8 weeks
Main outcome variables
Primary outcome:
Assessing hot flash before intervention and 8 weeks after that using standard questionnaire
Assessing night sweating before intervention and 8 weeks after that by history taking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N210
Registration date:2018-03-11, 1396/12/20
Registration timing:registered_while_recruiting
Last update:2018-03-11, 1396/12/20
Update count:0
Registration date
2018-03-11, 1396/12/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of the effect of combination of black Kohush - soybean and Primerose oil versus placebo on hot flash and night sweating in menopausal women: a double blind randomized clinical trial
Public title
Comparative of the effect of combination of black Kohush - soybean and Primerose oil versus placebo on hot flash and night sweating in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 45 to 80 years
Menopause
Exclusion criteria:
Any acute or chronic disease
Using any herbal drug during the past e months
Hypersensitivity to medicinal pants
Age
From 45 years old to 80 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
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
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UMSHA.REC.1396.822
Health conditions studied
1
Description of health condition studied
Menopaus
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Assessing hot flash
Timepoint
Before intervention and 8 weeks after that
Method of measurement
Using standard questionnaire
2
Description
Assessing night sweating
Timepoint
Before intervention and 8 weeks after that
Method of measurement
By history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Oral using a combination of black Kohush - soybean twice a day for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Using Primerose oil capsule twice a day for 8 weeks
Category
Treatment - Drugs
3
Description
Control group: Using placebo twice a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Hamadan City
Full name of responsible person
Dr. Seyyedeh Zahra Masoomi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyyedeh Zahra Masoomi
Position
Fertility Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyyedeh Zahra Masoomi
Position
Fertility Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available