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Effect of Boron supplementation on the severity of dysmenorrhea in female students residing in dormitories of Shaid Beheshti University of Medical sciences in 2013- 2014

Protocol summary

Summary
General objective: Determine effect of Boron supplementation on the severity of dysmenorrhea in female students residing in dormitories of Shaid Beheshti University of Medical sciences in 2013-14 Design of the study: randomized, triple blind, placebo-controlled. Methods of study: A) The study population: all female students of primary dysmenorrhea residing in dormitories of Shaid Beheshti University of Medical sciences in 2013-14. Study Sample: all female students residing in dormitories of Shaid Beheshti University of Medical sciences in2013-14 that having condition to enter the study. Inclusion criteria: being single; age between 18 – 25 year old; girls with primary dysmenorrhea that the pain intensity as moderate to severe based Mac Gill ruler; do not suffering from chronic diseases (diabetes, hypertension, cardiac diseases, infectious diseases, liver, kidney); regular menstruation (period between 21 – 35 days); normal BMI (19.8 – 25); have not any symptoms of itching, abnormal discharge during study; not taking any medication, supplements; they should not use any herbal remedies about 3 months ago Intervention; they should not have any deplorable event such as near relatives’ death or surgical operation in recent six months. Exclusion criteria: individual's consent to continue participating in the study; pelvic known pathology(myoma, pelvic tumor, endometriosis, PID) during the study; improper use of capsules; any use of herbal drug during the study. Sample size: 108. B)Intervention in study: use Boron supplementation. C)Intervention duration: 2 days before mensturation to 3 first day of bleeding. D) The primary outcome : reduce primery dysmenorrheal after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207153226N5
Registration date: 2014-05-21, 1393/02/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-21, 1393/02/31
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaid Beheshti University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Boron supplementation on the severity of dysmenorrhea in female students residing in dormitories of Shaid Beheshti University of Medical sciences in 2013- 2014
Public title
Effect of Boron supplementation on the severity of dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being single; age between 18 – 25 year old; girls with primary dysmenorrhea that the pain intensity as moderate to severe based Mac Gill ruler; do not suffering from chronic diseases (diabetes, hypertension, cardiac diseases, infectious diseases, liver, kidney); regular menstruation (period between 21 – 35 days); normal BMI (19.8 – 25); have not any symptoms of itching, abnormal discharge during study; not taking any medication, supplements; they should not use any herbal remedies about 3 months ago Intervention; they should not have any deplorable event such as near relatives’ death or surgical operation in recent six months. Exclusion criteria: individual's consent to continue participating in the study; pelvic known pathology(myoma, pelvic tumor, endometriosis, PID) during the study; improper use of capsules; any use of herbal drug during the study.
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
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
Shaid Beheshti University of Medical sciences
Street address
Shaid Beheshti University of Medical sciences- next to Taleghani Hospital- Yemen Street -Chamran Highway -Tehran
City
Tehran
Postal code
1985717443
Approval date
2014-02-09, 1392/11/20
Ethics committee reference number
400/7554

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea

Primary outcomes

1

Description
Severity of primary dysmenorrhea
Timepoint
Before the intervention, while following intervention during the 3 first day of bleeding in 2cycles.
Method of measurement
Verbal Multidimentional Scoring System Questionnaire, Mac gil ruler.

Secondary outcomes

1

Description
Complications
Timepoint
Finally of bleeding days
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: in people with inclusion criteria To be eaten Boron supplemental, 10 mg, oral daily((2 days before mensturation to 3 first day of bieeding) during 2 cycles. pain intensity with Systemic characteristics associated Will be recorded using Mac gil and Verbal Multidimentional Scoring System .
Category
Treatment - Drugs

2

Description
Control group: : in people with inclusion criteria To be eaten placebo, contains 300 mg of lactose powder, oral daily (2 days before mensturation to 3 first day of bieeding) during 2 cycles. . pain intensity with Systemic characteristics associated Will be recorded using Mac gil and Verbal Multidimentional Scoring System .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra’danshgah girl's dormitory, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nikkhah Somayeh// M.Sc Student of Midwifery
Street address
Front Rajai Heart Hospital//Highway intersection niayesh// Valiasr street/tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shaid Beheshti University of Medical sciences
Full name of responsible person
Dr. Masoumeh Simbar
Street address
School of Nursing and Midwifery Shahid Beheshtii/ Front Rajai Heart Hospital / Highway intersection niayesh/ Valiasr street/Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaid 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
Shaid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
MSc in midwifery
Other areas of specialty/work
Street address
Midwifery group /School of Nursing and Midwifery Shahid Beheshtii/ Front Rajai Heart Hospital / Highway intersection niayesh/ Valiasr street /Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
Email
mhdolatian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shaid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
MSc in midwifery of Shaid Beheshti University of Medical sciences
Other areas of specialty/work
Street address
Midwifery group /School of Nursing and Midwifery Shahid Beheshtii/ Front Rajai Heart Hospital / Highway intersection niayesh/ Valiasr street/Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
Email
mhdolatian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Nikkhah
Position
M.Sc Student of Midwifery
Other areas of specialty/work
Street address
Midwifery group /School of Nursing and Midwifery Shahid Beheshtii/ Front Rajai Heart Hospital / Highway intersection niayesh/ Valiasr street/Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 7710 1962
Fax
Email
nikkhah_somayeh@yahoo.com
Web page address
www.sbmu.ac.ir

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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