The purpose of this study is to evaluate the effect of soybean supplementation and regular aerobic exercise in water on mental and physical symptoms of premenstrual syndrome (PMS) in a randomized double-blinded clinical trial design. 92 single patients with PMS are students of Shahrood University of Technology and according to inclusion criteria such as patient between the ages 18-24 year old with normal menstrual cycle and exclusion criteria such as athlete patients with use of OCP (Combined oral contraceptives) or non-compliance with treatment and after being inform about the aim of present investigation and signed an informed consent form will randomly assign into four intervention groups, patients with PMS (23 girls) and regular aquatic exercise (doing water walking and crawl in the water with 50-60% heart rate for 30 minutes and doing water-polo for 20 minutes) during 8 weeks, patients with PMS and use of soybean supplementation (23 girls) that ingest 60 soybean supplementation capsules (one capsule each day after lunch) during 8 weeks, patients with PMS and regular aquatic exercise and use of soybean supplementation (23 girls) same as other intervention groups and control group: patients with PMS (23 girls) and use placebo (one capsule filled with Elaeagnus angustifolia powder which will administered by a blinded research assistant for each day after lunch during 8 weeks).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011221412N2
Registration date:2016-05-21, 1395/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Hamid Kalalian Moghadam
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
h.kalalian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-06-19, 1393/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of soybean supplementation and regular aerobic exercise in water on mental and physical symptoms of premenstrual syndrome (PMS) female students
Public title
Effect of soybean supplementation and regular aerobic exercise in water on mental and physical symptoms of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female gender between the ages 18-24 year old; Single; normal cycle (duration of cycle 21-35, bleeding 3-10 days); normal BMI with PMS.
Exclusion criteria: any history of disease such as hepatic; renal or respiratory cardiac; diabetes; or respiratory diseases, presence of secondary dysmenorrheal; sea food allergy; use of alcohol, smoking; presence of chronic diseases such as like migraine; use of any drug affecting PMS such as OCP or B6; stressful condition like death of family members.
Age
From 18 years old to 24 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
For elimination of the possibility of any probable bias due to the knowledge of patients and assessing physicians about the type of treatment we will perform a double blind study. Soybean supplementation and Elaeagnus angustifolia powder as placebo will be encapsulated and for this reason patients and assessing physicians do not have any knowledge about the type of treatment. Randomization will be performed by the Randlist software and every patient will be entered into four intervention groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Haftom Tir Square
City
Shahroud
Postal code
Approval date
2014-06-11, 1393/03/21
Ethics committee reference number
930/06
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome (PMS)
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
body fat percentage
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
2
Description
waist-to-hip ratio (WHR)
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
3
Description
premenstrual syndrome (existing symptoms in PSST questionnaire)
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
4
Description
Body water
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
5
Description
Fat-free mass index
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
6
Description
Body Mass Index
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
7
Description
skeletal muscle mass
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
8
Description
Body Fat Mass
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
9
Description
Weight
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
10
Description
Basal Metabolic Rate (BMR)
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
11
Description
body impedance analysis
Timepoint
8 weeks after intervention
Method of measurement
Body analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Contrtol group: patients with PMS (23 girls) which use placebo (one capsule filled with senjed powder for each day after lunch during 8 weeks)
Category
Placebo
2
Description
Intervention group: single patients with PMS during 8 weeks will use of one capsule of soybean supplementation each day
Category
Treatment - Drugs
3
Description
Intervention group: single patients (23 girls) with PMS and regular aquatic exercise during 8 weeks with 50-60% heart rate for 30 minutes
Category
Other
4
Description
Intervention group: patients with PMS (23 girls) and regular aquatic exercise with 50-60% heart rate for 30 minutes will use of one capsule of soybean supplementation each day during 8 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Street address
Shahroud University of Medical Sciences, Haftom Tir Square
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Street address
Shahroud University of Medical Sciences, Haftom Tir Square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahroud University of Medical Sciences
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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Position
Assistant Professor of Physiology,Shahroud University of Medical Sciences
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftom Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
h.kalalian@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences, Haftom Tir Square
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Position
Assistant Professor of Physiology,Shahroud University of Medical Sciences
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftom Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
h.kalalian@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Position
Assistant Professor of Physiology,Shahroud University of Medical Sciences
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftom Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
h.kalalian@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)