In this clinical trial, we determine the effect of primrose oil on the premenstrual syndrome. A total of 80 ladies aging 18 – 35 with the regular period of 24 – 30 days are recruited. They are randomly assigned into intervention or control group. The intervention group receives 1500 mg, 3 500 mg capsules, daily for 12 weeks) while the control group receive placebo. The severity of symptoms between two groups are measured using a measure rating 0 – 10, once monthly for 3 months, by a Obstetric and Gynecologist and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009214789N1
Registration date:2010-12-01, 1389/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Mandana Saki
Name of organization / entity
Lorestan Unuversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0140
Email address
saki.m@mail.lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Lorestan University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Primerose oil on Premenstrual syndrome
Public title
The effect of Primerose oil on Premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 - 35, having regular menstrual cycles with intervals 24 - 35 days , Without any physical diseases or specific drugs use, Analgesia drug for relieving pain , no record of mental diseases specially Depression disorder, no use of any anti depressants or hormonal drugs, no specific diet, no experience of stressful event during last 3 month from the beginning of the study and during the study
Exclusion criteria: Occurrence of the event during the study, having physical or mental diseases, pregnancy, lactation, menstrual cycle irregularity, medical diseases, using hormonal method of contraception
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Pardis Medical Campus, Kamalvand , ,
City
Khorram Abad
Postal code
381351698
Approval date
2010-05-19, 1389/02/29
Ethics committee reference number
27946/200--22/5/2010
Health conditions studied
1
Description of health condition studied
premenstural syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Intensity of the premenstrual syndrome
Timepoint
monthly during a period of 3 months
Method of measurement
The determination of total grade ( for any symptom from 0-10 )