This study is designed as a randomized, double-blind, placebo-controlled clinical trial to investigate effect of Zinc acetate in primary dysmenorrhea in female students of Islamic Azad University Falavarjan Branch dormitory. Then 78 students according to inclusion criteria will be enroll in the study after signing the informed consent sheet and randomly divided into2 groups. Inclusion criteria were included: having moderate and severe dysmenorrhea and normal cycle and exclusion criteria was improper administration of the medication. The participants in the first group took one capsule of Zinc acetate (30mg) daily for 3 days from beginning of menstruation for two consecutive cycles. Avicil PH110 was used for the placebo group. Intensity of pain was evaluated by Visual Analogue Scale (VAS) and a self-reported checklist was used to collect information of menstruation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062922982N1
Registration date:2016-05-17, 1395/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-17, 1395/02/28
Registrant information
Name
marzieh javanmardi
Name of organization / entity
islamic azad university falavarjan branch
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 2617
Email address
javanmardi_m@iaufala.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Falavarjan Branch
Expected recruitment start date
2013-12-18, 1392/09/27
Expected recruitment end date
2015-07-27, 1394/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Zinc acetate and placebo (Avicil PH110) effects on primary dysmenorrhea
Public title
Effect of Zinc acetate on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Single18 to25 years old students, intensity of pain was4 and more by visual analogue scale (VAS) , normal cycle (duration of cycle21-35 , bleeding3-7 days) , no history of abdominal or pelvic surgery or any specific disease such as hepatic, renal and cardiac diseases, diabetes, presence of secondary dysmenorrhea, non consumption of oral contraceptive pills in two months ago, no stressful condition in3 months ago and during the study like death of family members.
Exclusion criteria: Improper administration of the medication, administration of contraceptive pills or another medication whilst on research, severe stress, not to consent to continue the study.
Age
From 18 years old to 25 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Double blind means neither the researcher nor the patients know about the type of used drug in the accomplished study.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib Street, Isfahan
City
Isfahan
Postal code
Approval date
2013-04-22, 1392/02/02
Ethics committee reference number
492002
Health conditions studied
1
Description of health condition studied
dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
dismenorrhea
Timepoint
One month before the intervention and two months after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Capsule of Zinc acetate (30mg) daily for3 days from beginning of menstruation for two consecutive cycles
Category
Treatment - Drugs
2
Description
One capsule of placebo (Avicil PH110) daily for 3 days from beginning of menstruation for two consecutive cycles
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory of Islamic Azad University, Falavarjan Branch
Full name of responsible person
Marzieh Javanmardi
Street address
Islamic Azad University, Falavarjan Branch, Blvd. Daneshgah, Falavarjan
City
Falavarjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Islamic Azad Univercity, Falavarjan Branch
Full name of responsible person
Mrs Barati
Street address
Vice Chancellor for Research, Islamic Azad Univercity, Falavarjan Branch, Blvd. Daneshgah, Falavarjan
City
Falavarjan
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 Univercity, Falavarjan Branch
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 Univercity, Falavarjan Branch
Full name of responsible person
Marzieh Javanmardi
Position
Master of Science in Midwifry/Academic
Other areas of specialty/work
Street address
Islamic Azad Univercity, Falavarjan Branch, Blvd. Daneshgah, Falavarjan
City
Falavarjan
Postal code
Phone
+98 31 3742 0134
Fax
Email
javanmardi_m2008@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Falavarjan Branch
Full name of responsible person
Marzieh Javanmardi
Position
Master of Science in midwifry/Academic
Other areas of specialty/work
Street address
Islamic Azad University, Falavarjan Branch, Blvd. Daneshgah, Falavarjan
City
Falavarjan
Postal code
Phone
+98 31 3742 0145
Fax
Email
javanmardi_m2008@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Falavarjan Branch
Full name of responsible person
Marzieh Javanmardi
Position
Master of Science in Midwifry/Academic
Other areas of specialty/work
Street address
Blvd. Daneshgah, Falavarjan
City
Falavarjan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)