The effect of alpha-Lipoic Acid supplementation on symptoms of primary dysmenorrhea in students residing in the dormitory of Qazvin University of Medical Sciences : A randomized, single-blind, placebo-controlled clinical trial
Determine of bleeding time, severity of menstrual pain, duration of pain
Design
In this study, 80 girls with primary dysmenorrhea who are eligible to enter the study are selected. Participants are randomly assigned to four intervention and control groups and each participant is assigned a code.
Settings and conduct
This study is a single-blind randomized clinical trial. Girls with primary dysmenorrhea living in student dormitory at Qazvin University of Medical Sciences entered the study. Then, 80 patients were randomly assigned to four intervention and control groups. In this study, the patient will be blinded to drugs and placebo.
Participants/Inclusion and exclusion criteria
Girls with primary dysmenorrhea
Intervention groups
First intervention group: Alfalipoic acid recipient group (600 mg daily); Second intervention group: Mefenamic acid group (250 mg daily); Third intervention group: Alfalipoic acid (600 mg daily) + Mefenamic acid (250 mg daily), control group: placebo group
Main outcome variables
Duration of bleeding, pain intensity of menstruation, duration of pain
General information
Reason for update
Acronym
ALA
IRCT registration information
IRCT registration number:IRCT20141025019669N8
Registration date:2018-02-09, 1396/11/20
Registration timing:registered_while_recruiting
Last update:2018-02-09, 1396/11/20
Update count:0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alpha-Lipoic Acid supplementation on symptoms of primary dysmenorrhea in students residing in the dormitory of Qazvin University of Medical Sciences : A randomized, single-blind, placebo-controlled clinical trial
Public title
Alpha-Lipoic acid supplementation on symptoms of dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having primary dysmenorrhea
Having regular menstruation between 35-21 days
Single
Having a body mass index below 30
Exclusion criteria:
Having secondary dysmenorrhea (endometriosis, adenomyosis, leiomyoma, uterine anomaly, Endometrial Polyps, ovarian cyst)
Intake of antioxidant supplement in the last six months
Age
From 18 years old to 25 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are randomly divided into two groups, intervention and control groups, using randomized distribution method. In this study, the patient is blinded to medicine and placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University Of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-01-22, 1396/11/02
Ethics committee reference number
IR.QUMS.REC.1396.387
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Duration of bleeding
Timepoint
Before the intervention and after the intervention
Method of measurement
According to a person's report by the questionnaire
2
Description
Pain duration
Timepoint
Before the intervention and after the intervention
Method of measurement
Duration of pain based on hours
3
Description
Intensity of pain
Timepoint
Before the intervention and after the intervention
Method of measurement
Pain intensity according to the questionnaire
Secondary outcomes
1
Description
Pain duration
Timepoint
Before the intervention and after the intervention
Method of measurement
Duration of pain based on hours
Intervention groups
1
Description
Intervention group: Alfalipoic acid, 600 mg per daily
Category
Treatment - Drugs
2
Description
Intervention group: Mefenamic acid, 250 mg per day