Protocol summary

Summary
Objectives: To Compare the Effect of Vitamins E, B6, Calcium and Omega-3 Fatty Acids in the Treatment of Severe Mental and Physical Symptoms of Premenstrual Syndrome. Design: In this Clinical Trial, Female Students of Islamic Azad University of Sari Branch Will be Selected On the Basis of Inclusion and Exclusion Criteria of the Study and Will Fill in the Rosignol Bonlender’s Check list of the Standard Symptoms for 3 Months to Diagnose the Premenstrual Syndrome. 200 Female Patients With Moderate and Severe Forms of the Syndrome are Randomly Assigned to Five Treatment Groups. Setting & Conduct: First Group Received 1g Calcium, During Last 7 Days of the Cycle for Three Months, the Second Group Took 100 mg of Vitamin E Daily for Three Months, the Third Group Received 1 g Capsule of Fish Oil Daily for Three Months, the Forth Group Received 40 mg of Vitamin B6 Daily for Three Months, and the Last Group Received Daily One Tablet of Placebo for Three Months. In This Three Months Period, Rosignol Bonlender’s Check List of Symptoms was Also Filled. Participants With Main Inclusion and Exclusion Criteria: Single Girls With Age From 18 to 30 Years With Regular Menstrual Cycles or Cycles Between 21-35 Days Were Included in the Study. And Those Who Were Breast Feeding, Taking Hormonal Contraceptive pills, Had a History of Mental Illnesses Such as Depression, Had Traumatic Problems Within 2 Months Ago or Took Antidepressants or Herbal Within 6 Months were Excluded From the Study. Interventions: Vitamin E, Vitamin B6, Calcium, Omega-3 Fatty Acids and Placebo. Outcome Variables: Severity of Mental Symptoms, Severity of Physical Symptoms, Severity of Premenstrual Syndrome Before and After the Treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012123010705N1
Registration date: 2013-01-22, 1391/11/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-22, 1391/11/03
Registrant information
Name
Mandana Zafari
Name of organization / entity
Islamic Azad Universirt Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 15 1229 2263
Email address
mandanazafari@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Islamic Azad University Sari Branch, Darya Bolvar, Khazar Square, Sari, Mazandaran, Iran.
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Vit E, Vit B6, Calcium and Omega-3 on Treatment of Premenstrual Syndrome In Student of Islamic Azad University Sari Branch
Public title
Effect of Vit E, Vit B6, Calcium and Omega-3 on Treatment of Premenstrual Syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Single Girls, Aged Between 18-30 Years Old, Having Regular Menstrual Cycles, Duration of the Cycle Between 21-35 Days, Having Moderate and Sever Form of Premenstrual Syndrome According to the Standard Questionnaire of Rosignol Bonlender. Exclusion Criteria: Breast Feeding, Use of Oral Contraceptive Pills, Having a History of Psychological Diseases Such as Depression, Traumatic Problems During the Past Two Months, Taking Antidepressants and Herbal Drugs 6 Months Ago.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Islamic Azad University Sari Branch
Street address
Vice Chancellor for Research, Islamic Azad University Sari Branch, Sari, Mazandaran, Iran
City
Sari
Postal code
48161-19318
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
1391-4

Health conditions studied

1

Description of health condition studied
Premenstrual syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual Tension Syndrome

Primary outcomes

1

Description
Severity of Premenstrual Syndrom
Timepoint
Before and Three Months After Treatment
Method of measurement
Rosignol Bonlender Questionnair & Checklist

Secondary outcomes

1

Description
Severity of Physical Symptoms of Premenstrual Syndrom
Timepoint
Before Treatment and Three Months After Treatment
Method of measurement
Rosignol Bonlender Questionnaire

2

Description
Severity of Psycological Symptoms of Premenstrual Syndrom
Timepoint
Before Treatment and Three Months After Treatment
Method of measurement
Rosignol Bonlender Questionnaire

3

Description
Severity of Premenstrual Syndrom
Timepoint
Before Treatment and Three Months After Treatment
Method of measurement
Rosignol Bonlender Questionnaire

Intervention groups

1

Description
Vit E : Receiving vit E 100 mg/day For Three Months
Category
Treatment - Drugs

2

Description
Calcium 1 gram: Receiving 1 gram Calcium During 7 Days End of Cycle for Three Months.
Category
Treatment - Drugs

3

Description
Capsule of Fish Oil: Receiving 1 gram Capsule Every Day for Three Months
Category
Treatment - Drugs

4

Description
Vit B6 : Receiving 40 mg/ Day for Three Months
Category
Treatment - Drugs

5

Description
Placebo: Receiving 1 / Day for Three Months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dormitory & Colleges of Islamic Azad University Sari Branch, Darya Bolvar, Khazar Square, Sari, Maz
Full name of responsible person
Hamed Samadi
Street address
Islamic Azad University Sari Branch, Darya Bolvar, Khazar Squar, Sari, Mazandaran, Iran.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Islamic Azad University Sari Branch, Darya Bolvar, Khazar Square, Sari
Full name of responsible person
Hamed Samadi
Street address
Vice Chancellor for Research, Islamic Azad University Sari Branch, Darya Bolvar, Khazar Square, Sari, Mazandaran, Iran
City
Sari
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, Islamic Azad University Sari Branch, Darya Bolvar, Khazar Square, Sari
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
Islamic Azad University Sari Branch
Full name of responsible person
Mandana Zafari
Position
PhD Student of Thalassemi, Faculty Member
Other areas of specialty/work
Street address
Islamic Azad University Sari Branch, Darya Bolvar, khazar Squar, Sari, Mazandaran, Iran
City
Sari
Postal code
4816715691
Phone
+98 15 1229 2263
Fax
Email
mandanazafari@yahoo.com; mandanazafari@iausari.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Mandana Zafari
Position
PhD Student of Thalassemia
Other areas of specialty/work
Street address
Islamic Azad University Sari Branch, Darya Bolvar, Khazar square, Sari, Mazandaran, Iran
City
Sari
Postal code
1816715691
Phone
+98 15 1229 2263
Fax
Email
mandanazafari@yahoo.com; mandanazafari@iausari.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Mandana Zafari
Position
PhD Student of Thalassemia/ Faculty Member
Other areas of specialty/work
Street address
Islamic Azad University Sari Branch, Darya Bolvar, Khazar Square, Sari, Mazandaran, Iran
City
Sari
Postal code
48167-15691
Phone
+98 15 1229 2263
Fax
Email
mandanazafari@yahoo.com ; mandanazafari@iausari.ac.ir
Web page address

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
Loading...