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Evaluation the effect of wheat germ extract capsules on the severity of Premenstural symptomes in women employed in hospitals in Hamadan

Protocol summary

Summary
This study aims to determine the effects of wheat germ extract capsules on premenstural syndrome symptoms in women employed in hospitals affiliated to Hamedan University of Medical Sciences. Inclusion criteria: age should be between 20 and 45 years; BMI should be between 19/8 and 26; they should be non smokers. they should have 3 to 10 days bleeding in two months prior to study; Regular menstrual cycles should be 21-35 days; premenstural syndrome based on pre menstural syndrome provisional diagnosis questionnaire and daily form showing premenstural syndrome symptoms after 2 months should be proved; they should have no known mental illnesses; they should have no physical illnesses such as diabetes, seizure disorders, hypothyroidism and so on; There should be no death of close relatives, divorce or other adverse events in the last 3 months; Surgery should not be performed in the three months before entering study; Antidepressants, hormonal contraceptives, medroxy progesterone acetate, and vitamins should not be taken in the past three months; Exclusion criteria: pregnancy, incidents like the death of close relatives, divorce, and other adverse events; taking 3 capsules of wheat germ or less on two consecutive days, taking supplements, eating wheat germ. this study is done using triple blind, controlled clinical trial method on 84 women working in the morning shift at the hospital in Hamadan. participants complete daily symptom record form for two consecutive months and after definitive diagnosis of premenstural syndrome are randomly divided into two groups of 42 and for two consecutive months, they take 400 mg capsules of wheat germ extract 3 times daily from day 16 of menstrual cycle untill day 5 of menstrual cycle. Data are analyzed using SPSS-17 and descriptive statistics to assess the severity of premenstural syndrome.

General information

Acronym
Premenstural syndrom
IRCT registration information
IRCT registration number: IRCT201310286807N8
Registration date: 2013-12-21, 1392/09/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-21, 1392/09/30
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of wheat germ extract capsules on the severity of Premenstural symptomes in women employed in hospitals in Hamadan
Public title
Effect of wheat germ juice on premenstural syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age should be between 20 and 45 years; BMI should be between 19/8 and 26; they should be non smokers; they should have 3 to 10 days bleeding in two months prior to study; Regular menstrual cycles should be 21-35 days; premenstural syndrome based on premenstural syndrome provisional diagnosis questionnaire and daily form showing premenstural syndrome symptoms after 2 months should be proved; they should have no known mental illnesses; they should have no physical illnesses such as diabetes, seizure disorders, hypothyroidism and so on; There should be no death of close relatives; divorce or other adverse events in the last 3 months; Surgery should not be performed in the three months before entering study; Antidepressants, hormonal contraceptives, medroxy progesterone acetate, and vitamins should not be taken in the past three months; Exclusion criteria: pregnancy; incidents like the death of close relatives, divorce, and other adverse events; taking 3 capsules of wheat germ or less on two consecutive days; taking supplements; eating wheat germ.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Ethic committee of International branch of Shahid Beheshti University of Medical Sciences
Street address
Tehran, next to Hemmat Bridge, International branch of Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-10-07, 1392/07/15
Ethics committee reference number
116/2879

Health conditions studied

1

Description of health condition studied
pre menstural syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Severity of pre menstural syndrome
Timepoint
8 weeks Before treatment, 8 weeks after treatment
Method of measurement
Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: wheat germ extract, capsules, 400 mg orally, three times a day for two months
Category
Treatment - Drugs

2

Description
Control group: Starch, Capsule 400 mg orally three times a day for two consecutive months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mr. Kazemi
Street address
Hamadan, next to the station, the prison turn, Farshchian Hospital
City
Hamedan

2

Recruitment center
Name of recruitment center
Boali Hospital
Full name of responsible person
Mrs. Shahidi
Street address
Hamadan, next to Luna park, Boali Hospital
City
Hamadan

3

Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Mr.Bagheri
Street address
Hamadan, University Square, Ekbatan Hospital
City
Hamadan

4

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mr.Shahrokhi
Street address
Hamadan, Besat Hospital
City
Hamadan

5

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Mr.Zolhavarie
Street address
next to Luna park, Eram Blvd, Beheshti Hospital
City
Hamedan

6

Recruitment center
Name of recruitment center
Fatemiyyeh Hospital
Full name of responsible person
Mrs. Abubzade
Street address
Kermanshah Street, Fatemiyyeh Hospital
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Kiandokht Ghanati
Street address
Tehran, next to Hemmat Bridge, International branch of Shahid Beheshti University of Medical Sciences
City
Tehran
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 of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddighe Amir Ali Akbari
Position
Msc
Other areas of specialty/work
Street address
Tehran, Niayesh, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Fax
+98 21 2272 9238
Email
asa_akbari@yahoo.com
Web page address
sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddighe Amir Ali Akbari
Position
Msc
Other areas of specialty/work
Street address
Tehran, Niayesh, School of Nursing and Midwifery
City
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Fax
+98 21 2272 9238
Email
asa_akbari@yahoo.com
Web page address
sbmu.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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