The aim of the present study is to assess the effects of anise abstract on relief and recurrence of menopausal hot flashes in postmenopausal women in Qazvin. A total of 72 postmenopausal women were randomly assigned into intervention or control group to receive either 100mg capsules of anise abstract or 330mg capsules of starch powder, 3 times a day for 4 weeks. The frequency and severity of hot flashes were measured and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904144317N1
Registration date:2010-10-06, 1389/07/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-06, 1389/07/14
Registrant information
Name
Fatemeh Nahidi
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 982188202512
Email address
nahidi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of Medical Sciences and Health Services
Expected recruitment start date
2008-08-02, 1387/05/12
Expected recruitment end date
2010-02-18, 1388/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study on the effects of anise abstract on relief and recurrence of menopausal hot flashes in Qazvin
Public title
The study on the effects of anise abstract on relief and recurrence of menopausal hot flashes in Qazvin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 45-60, history of amenorrhea at least 1 and at most 3 years prior to the study, experience of hot flashes, being literate or having a literate family member, married or widowed since one year prior to the study, not using food or herbal medicine content of phytoestrogens
Exclusion criteria: confirmed diabetes, hyperthyroidism, hypothyroidism or any other diseases causing hot flash, undergoing hormone therapy, taking anticoagulant, anti depressive or anxiolytic drugs, hypersensitivity to anise, experiencing stressful events such as divorce, death of her husband, or death of her close family members during 6 months prior to the study
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:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti University of Medical Sciences and Health Services
Street address
Iran
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
9242
Health conditions studied
1
Description of health condition studied
Hot flash
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hot flosh
Timepoint
2 weeks before treatment and 4 weeks after treatment (1st, 2nd, 3rd, and 4th week) and 4 week for follow up
Method of measurement
Information form
Secondary outcomes
empty
Intervention groups
1
Description
Anise abstract, 100mg capsules, 3 times a day, for 4 weeks
Category
Treatment - Drugs
2
Description
Placebo, 330 mg starch capsules, 3 times a day, for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health and Medical centers of Qazvin
Full name of responsible person
Fatemeh Nahidi and Maryam Taherpour
Street address
Qazvin University of Medical Sciences
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Fatemeh Nahidi
Street address
Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Beheshti University of Medical Sciences and Health Services
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
Shaheed Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member of Shaheed Beheshti University of Medical Sciences ,MSc in Midwifery and student o
Other areas of specialty/work
Street address
Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4421 8052
Fax
Email
nahidifateme@yahoo.com, nahidi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Nahidi
Position
MSc in midwifery and student of PhD in Health Education
Other areas of specialty/work
Street address
Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4421 8052
Fax
Email
nahidi@sbmu.ac.ir nahidifateme@yahoo,com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member, MSc in Midwifery and student of PhD in Health Education
Other areas of specialty/work
Street address
Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 4421 8052
Fax
Email
nahidifateme@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)