The study on effects of anise abstract on relief and recurrence of menopausal hot flashes in health care centers affiliated to Shahid Beheshti Medical University
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 health care centers affiliated to Shahid Beheshti Medical University. A total of 72 postmenopausal women will be randomly assigned into intervention or control group to receive either 330 mg capsules of anise abstract or 330mg capsules of starch powder, 3 times a day for 4 weeks. The frequency and severity of hot flashes will be measured and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103284317N4
Registration date:2011-05-15, 1390/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-15, 1390/02/25
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
The Pharmaceutical Sciences Research Center, Shahid Beheshti Medical Sciences University
Expected recruitment start date
2009-12-21, 1388/09/30
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study on effects of anise abstract on relief and recurrence of menopausal hot flashes in health care centers affiliated to Shahid Beheshti Medical University
Public title
The effects of anise abstract on relief and recurrence of menopausal hot flashes
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 phyptoestrogens. There was not confirmed of 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
Exclusion criteria: The subjects were decided to use drug or hormone and herbals medicin to relieve hot flashes.
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
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti University of Med Sciences
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
Approval date
2010-01-03, 1388/10/13
Ethics committee reference number
5695-114-01-87
Health conditions studied
1
Description of health condition studied
Hot flash
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Recurrence
Timepoint
Weekly
Method of measurement
Study data sheet
2
Description
Frequency of hot flash
Timepoint
Weekly from two weeks before intervention to four weeks after intervention
Method of measurement
Study data sheet
3
Description
Severity of hot flash
Timepoint
Weekly from two weeks before intervention to four weeks after intervention
Method of measurement
Study data sheet
Secondary outcomes
1
Description
Weight
Timepoint
Weekly
Method of measurement
Scale
Intervention groups
1
Description
Interventionl group will take capsules containing 330mg anise abstract for 8 weeks 3 times a day (morning, noon and night).
Category
Treatment - Drugs
2
Description
Control group will take placebo capsulescontaining 330mg starch with the same shape for 8 weeks 3 times a day (morning, noon and night).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers affiliated to Shahid Beheshti Medical University
Full name of responsible person
Fatemeh Nahidi faculty member of Shaheed Beheshti University of Medical Sciences ,MSc in Midwifery a
Street address
Health care centers affiliated to Shahid Beheshti Medical University
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Sciences Research Center
Full name of responsible person
Farshad H. Shirazi
Street address
Pharmaceutical Sciences Research Center ,School of Medicien, Below of Niyayesh,Avenue Valiasr
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences Research Center
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
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
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 2243 9912
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
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
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)