The aim of this study was to compare the effect of Manhae and hormone replacement therapy (HRT) on hot flashes in postmenopausal women. In this single blind randomized controlled trial, 60 eligible postmenopausal women(30 women in each group) recruited randomly and have been studied. The Manhae group was treated with Manhae (850 mg daily) and HRT group was treated with (0/312 mg conjugated estrogen plus 2/5 mg medroxyprogesterone daily). Two groups followed-up for 12 weeks. primary outcomes: number and severity of hot flashes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092410926N1
Registration date:2012-11-09, 1391/08/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-09, 1391/08/19
Registrant information
Name
Maryam Honarjoo
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 2322 2101
Email address
honarjoo@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2012-08-10, 1391/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion the effect of Manhae and Hormone Replacment Therapy (HRT) on Hot flushes in postMenopausal Women
Public title
Effect of manhae on hot flushes in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: experiencing least 4 hot flushes per day and time of amenorrhea between 1 and 5 year; being literate; BMI 19/8-29 and age 45-55 years old.
Exclusion criteria: any known diseases;disease: breast, cervix, uterine, ovarian; use of supplementary nutritions; smoking and abnormal menopause due to radiotherapy and ovariectomy.
Age
From 45 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ahvaz jundishapur university of medical sciences
Street address
golestan-ahvaz jundishapur university of medical sciences
City
ahvaz
Postal code
6341773637
Approval date
2012-03-04, 1390/12/14
Ethics committee reference number
eth-576
Health conditions studied
1
Description of health condition studied
Hot flushes
ICD-10 code
R23.2
ICD-10 code description
Flushing
Primary outcomes
1
Description
number of Hot flushes
Timepoint
Before intervention, 1, 2, 3, 4, 6, 8, 10 and 12 weeks after
Method of measurement
number of Hot flushes f per day
2
Description
severity of Hot flushes
Timepoint
Before intervention, 1, 2, 3, 4, 6, 8, 10 and 12 weeks after