The aim of the present study is to assess the effects of Licorice on relief and recurrence of menopausal hot flashes in postmenopausal women referring to healthcare centers affiliated to Shahid Beheshti Medical University. A total of 90 postmenopausal women were randomly assigned into intervention or control group to receive either 330mg capsules of Licorice or 330mg capsules of starch powder, 3 times a day for 8 weeks. The frequency and severity of hot flashes measure and compare between the two groups (At the end of each week, for 2 weeks before the intervention, for 8 weeks of the intervention for 4 weeks of followed up stage).
General information
Acronym
Hot Flashes
IRCT registration information
IRCT registration number:IRCT201103264317N3
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 of Shahid Beheshti Medical Sciences University providing facilities and funding source to conduct this study.
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2009-12-21, 1388/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Licorice on Relief and Recurrence of Menopausal Hot Flashes
Public title
Effects of Licorice on Relief and Recurrence of Menopausal Hot Flashes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The subjects were between 45-60, had body mass index (BMI) under 29, experienced amenorrhea at least 1 year or at most 3 years, suffered from hot flash and used no drug or hormone to relieve it. In addition, they had no known disease in their medical records, didn’t take antidepressants or sedatives, were married or lost their husbands not sooner than 1 year, experienced no stressful event (e.g. death of close family members, divorce etc.) in the past 6 months, were not vegetarian or had no allergy to herbs as well as no history of estrogenic cancers in themselves or their close relatives.
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Age, duration of amenorrhea as well as onset, frequency and severity of hot flash as intervening variables were matched
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti University of Medical Sciences and Health Services
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
2010-01-21, 1388/11/01
Ethics committee reference number
5538-114-03-86
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
Relief
Timepoint
Weekly
Method of measurement
Information form
2
Description
Recurrence
Timepoint
Weekly
Method of measurement
Information form
3
Description
Frequency of hot flash
Timepoint
At the end of each week, for 2 weeks before the intervention , for 8 weeks of the intervention for 4 weeks of followed up stage
Method of measurement
Information form
4
Description
Severity of hot flash
Timepoint
At the end of each week, for 2 weeks before the intervention , for 8 weeks of the intervention for 4 weeks of followed up stage
Method of measurement
Information form
Secondary outcomes
1
Description
Daily food intake
Timepoint
At the end of each week
Method of measurement
Information form
2
Description
Blood pressure
Timepoint
Weekly
Method of measurement
Sphygmomanometer( instrument for measuring blood pressure)
3
Description
Weight
Timepoint
Weekly
Method of measurement
Scale
Intervention groups
1
Description
Licorice capsules contained 330mg licorice root abstract.The subjects took them for 8 weeks 3 times a day (morning, noon and night).
Category
Treatment - Drugs
2
Description
Placebo capsules had 330mg starch with the same shape. The subjects in control group took them 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
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sbmu Pharmaceutical Sciences Research Center
Full name of responsible person
Farshad H. Shirazi
Street address
Sbmu 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
Sbmu 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 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 of P
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
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
nahidifateme@yahoo.com , nahidi@sbmu.ac.ir
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
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)