The objective of this study is to compare the effects of omega–3 and placebo in relieving menopausal symptoms, especially hot flash. In this double blind randomized clinical trial, Sixty healthy women suffering from hot flash with their menopause beginning about 12 months (6 to 18 months) were assigned to placebo and omega–3 groups, to evaluate hot flash severity and rate of attacks. Patients took the drug daily for 3 months. (omega-3, 1000mg daily and placebo with the same appearance once daily) and the severity and rate of attacks compared before beginning of treatment and monthly during the study and then at the 3rd and sixth month after ending the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102165737N1
Registration date:2011-04-06, 1390/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-06, 1390/01/17
Registrant information
Name
Azadeh Rezaee
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 6926
Email address
azadehrezaee@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2009-11-21, 1388/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of omega3 effect versus placebo on hot flash in peri-menopausal women
Public title
The effect of omega3 on hot flash
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 45 to55 years, BMI=20-30, FSH>20, Having 2 hot flash attack per day Exclusion criteria: using clonidin, anti depressant agents, tamoxifen, raloxifen, antibiotics, anti acids, soya, vit E, or anti coagulants, any hormone therapy in the last 6 month, fish allergy
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:
60
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
Tehran University of Medical Sciences and Health Services
Street address
Pardis unit/Shahid Hemat high way/Tehran
City
Tehran
Postal code
Approval date
2009-04-29, 1388/02/09
Ethics committee reference number
13273
Health conditions studied
1
Description of health condition studied
Hot flash
ICD-10 code
r50,r51,r5
ICD-10 code description
General symptoms and signs
Primary outcomes
1
Description
rate of hot flash
Timepoint
before intervention/after each month of intervention/3,6month after intervention ended
Method of measurement
counting number of hot flash attack
2
Description
severity of hot flash
Timepoint
before intervention/after each month of intervention/3,6 month after intervention ended