Background: Premenstrual syndrome (PMS) is among the most prevalent disorders of the fertility ages. It affects the individual's activities in family and society. Regarding its problems and difficulties, the related medical interventions are considered of great importance.
Objective: The aim of this research is considering the effect of using Zinc sulphate on the life quality of the patients suffering from premenstrual syndrome.
Method: The research was conducted in two stages. The first stage related to specifying and recognizing the people suffering from medium to severe PMS. The second stage was the blind technique randomize clinical. At the first stage, some female students of the Tehran and Tarbiat Modares Universities residing dormitoreis were selected randomly and filled 530 PSST questionnaires (PSST questionnaire psychometrics was conducted in this case for the first time); the PMS patients were recognized. At the second stage among 275 patients, 142 samples qualified for trial. They entered the study after signing the written consent form; they classified in two groups of control and test equally. At last data related to 130 samples were analyzed statistically. The samples received Zinc sulphate and Plasbo in three menstrual period and reported the results at the end of each period. They also filled SF12 questionnaire i.e. a summary form of SF36 life quality (which is standardized in Iran). It has restricted to two physical and mental aspects.
Key Words: Premenstrual syndrome, zinc sulphate, life quality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809232852N1
Registration date:2010-06-06, 1389/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-06, 1389/03/16
Registrant information
Name
Shiva Siahbbazi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 1001
Email address
siahbazi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University Faculity of Medical Sciences
Expected recruitment start date
2009-01-02, 1387/10/13
Expected recruitment end date
2010-01-07, 1388/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Zinc sulfate Consumption In Premenstrual Syndrome: Measuring Its Effects on Quality of Life Using the PSST& SF12 Questionnairs
Public title
Zinc sulfate Consumption In Premenstrual Syndrome: Measuring Its Effects on Quality of Life Using the PSST& SF12 Questionnairs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: being single, suffering from moderate to severe PMS based on PSST questionnaires, age between 20 and 35 year with regular and normal menstruation (menstrual cycle 22 to 35 days and duration of bleeding 3 to 7 days), Normal BMI (26-19) Exclusion criteria: cardiovascular, pulmonary, renal, diabetes, liver, gastrointestinal, gynecological, and thromboembolic diseases, including chronic migraines, mental illness, taking any medication, and being under severe stress such as death of loved ones etc in the past three months, smoking and alcohol consumption, and consuming too much or too little food based on the questionnaire 1
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
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
Tarbiat Modarres University
Street address
Tehran, Jalal Al Ahmad St., Chamran Highway Intersection
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
15070892
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Symptoms of Premenstrual Syndrome
Timepoint
Before intervention, the first month, second month and third month after the intervention
Method of measurement
Psst Questionnaire
2
Description
Quality of life
Timepoint
Before intervention, the first month, second month and third month
Method of measurement
sf12 Questionnaire
Secondary outcomes
1
Description
Side effects, including gastrointestinal
Timepoint
After 3 month
Method of measurement
Questionnaire
2
Description
Tendency for future medication use
Timepoint
After 3 month
Method of measurement
Questionnaire
3
Description
Dysmenorrhea
Timepoint
After 3 month
Method of measurement
Questionnaire
Intervention groups
1
Description
Intrvention group Zinc sulfate
Category
Treatment - Drugs
2
Description
Control group Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Shiva Siahbazi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Tehran university
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares Univresity
Full name of responsible person
Dr Lida Moghaddam
Street address
Tehran Tarbiat Modares Univrecity-Faculty of Medical Sciences 5 Midwifery group
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares Univresity
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
Tarbiat Modares University
Full name of responsible person
Shiva Siahbazi
Position
Master of Sciences of Midwifery
Other areas of specialty/work
Street address
Tehran Tarbiat Modares University
City
Tehran
Postal code
Phone
+98 21 6603 5351
Fax
Email
SIAHBAZI@Modares.ac.ir;shiva_siahbazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares Univesity
Full name of responsible person
Shiva Siahbazi
Position
Master Of Sciences In Midwifery
Other areas of specialty/work
Street address
Tehran -Tarbiat Modares Univesity-Department of Midwifery
City
Tehran
Postal code
Phone
+98 21 6603 5351
Fax
Email
SIAHBAZI@Modares.ac.ir;shiva_siahbazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shiva Siahbazi
Position
Other areas of specialty/work
Street address
City
TEHRAN
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)