Background:
Hot flash is most common of menopausal women, that destroys sleep quality and decrease ability of prevail over stress and after days difficult. one of the complement therapies for it is phytoestrogens that rich sources of them find in Iran abundantly that are affordable and reasonable are Fenugreek seed, flaxseed and soy. The goal of research is comparison of the effect of fenugreek seed, Flaxseed and soy on menopausal hot flashes.
Material and Methods:
A prospective randomize control trial will conduct on 120 women in menopause age that will assign to equal four groups : Fenugreek seed group (6g daily ), Flaxseed group (25 g daily ) , Soy group ( 25 g daily ) and Wheat group (25 g daily ) for 4 weeks consequently.
Women with amenorrhea during the previous 12 months with reporting menopausal hot flash , normal blood pressure without use of estrogen and progesterone, anti depressant and anti anxiety drugs during the previous 6 months as well as with out use of anticoagulants and NSAIDs for example ibuprofen and with out history of asthma and allergy will include in the research. Women with incorrect use of herbal plants, home change and skin irritation will exclude from study.
Hot flash frequency and intensity will determine and analyzed in initial time of study, fourth and eight weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807122545N1
Registration date:2011-07-24, 1390/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Naimeh Akbaritorkestani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3500
Email address
n.akbary@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences.
Expected recruitment start date
2008-07-20, 1387/04/30
Expected recruitment end date
2010-07-21, 1389/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of fenugreek seed, Flaxseed and soy on hot flashes menopause.
Public title
The comparison of the effect of fenugreek seed, Flaxseed and soy on hot flashes menopause.
Purpose
Treatment
Inclusion/Exclusion criteria
Women with amenorrhea during the previous 12 months with reporting menopausal hot flash , normal blood pressure without use of estrogen and progesterone, anti depressant and anti anxiety drugs during the previous 6 months as well as with out use of anticoagulants and NSAIDs for example ibuprofen and with out history of asthma and allergy will include in the research. Women with incorrect use of herbal plants, home change and skin irritation will exclude from study.
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
this study is experimental enter 120 women (sample size estimate whit a=%5 b=%20 Sd=1/5 d=1) 24woman in every group that employee in every group 30 woman.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences, Arak , Iran .
Street address
Arak University of Medical Sciences, Sardasht, Arak, Iran.
City
Arak
Postal code
3848176941
Approval date
2008-05-09, 1387/02/20
Ethics committee reference number
276
Health conditions studied
1
Description of health condition studied
Menopausal hot flash
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
frequency of hot flash
Timepoint
Initial of intervention and 4 week and 8 weeks after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Intensity of hotflashs
Timepoint
initial of study,4 , 8 weeks after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Fenugreek seed group (6g daily) for 4 weeks consequently
Category
Treatment - Drugs
2
Description
Flaxseed group (25 g daily )for 4 weeks consequently.
Category
Treatment - Drugs
3
Description
Soy group ( 25 g daily )for 4 weeks consequently
Category
Treatment - Drugs
4
Description
Wheat group (25 g daily ) for 4 weeks consequently
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences, Arak, Iran.
Full name of responsible person
Naimeh Akbari Torkestani
Street address
Arak university of medical science, Sardasht, Arak, Iran.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences.
Full name of responsible person
Dr. Said Changizi Ashtiyani
Street address
Arak University of Mdical Sciences, Sardasht, Arak, Iran.
City
Arak
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, Arak 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
Arak University of Medical Sciences , Arak , Iran .
Full name of responsible person
Naimeh Akbari Torkestani
Position
master degree of midwifery
Other areas of specialty/work
Street address
Arak University of Medical Sciences , Sardasht , Arak , Iran .
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3503
Fax
Email
tnaimeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences, Arak, Iran .
Full name of responsible person
Naimeh Akbari Torkestani
Position
master degree of midwifery
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Sardasht, Arak, Iran.
City
Arak
Postal code
3848176941
Phone
+98 86 1312 1955
Fax
Email
tnaimeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences, Arak, Iran.
Full name of responsible person
Naimeh Akbari Torkestani
Position
master degree of midwifery
Other areas of specialty/work
Street address
Arak University of Medical Science, Sardasht, Arak, Iran.
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3503
Fax
Email
tnaimeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)