Protocol summary

Summary
Premenstrual syndrome is one of the most common health problems in women, affecting 20-40% of women in reproductive age. All the medicines prescribed for eliminating the intensity of premenstrual syndrome have some adverse effects. Therefore, this research is aimed to determine the effect of Crocus Sativus L. (saffron) on the intensity of PMS in the female university students resident in Lorestan University of Medical Sciences dormitories. This research is a randomized controlled trial on 88 students resident in dormitory with the age of 18-35 years, regular menstrual cycles, and experience of PMS symptoms. We will assign our subjects to receive capsules of C.Sativus, 30 mg/day (15mg, twice a day) or placebo (twice a day) for two menstrual cycles. Severity of symptoms will be compared between groups through DASS21 criteria and premenstrual assessment form.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138807292618N1
Registration date: 2010-02-05, 1388/11/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-02-05, 1388/11/16
Registrant information
Name
Soheila Pirdadeh Beiranvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1322 9095
Email address
s.pirdadeh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Crocus Sativus L.(saffron) on the intensity of PMS in the female university students
Public title
The effect of Crocus Sativus L.(saffron) on the intensity of PMS in the female university students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-35 years, residence in dormitory, having regular menstrual cycles, experience of PMS symptoms. Exclusion criteria: pregnancy, lactation, menstrual cycle irregularity, medical disease, hormonal method of contraception
Age
From 18 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 88
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
Deputy of Research and Information Technology
Street address
Razi st, Enghelab Ave, Khorramabad, Lorestan, Iran
City
khorramabad
Postal code
6814989468
Approval date
empty
Ethics committee reference number
200/16172

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
Intensity of the premenstrual syndrome
Timepoint
daily
Method of measurement
premenstrual assessment form

Secondary outcomes

empty

Intervention groups

1

Description
C.Sativus capsule, 30 mg/day (15 mg, twice a day) for 8 weeks
Category
Treatment - Drugs

2

Description
Placebo capsule (twice a day) for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences dormitories
Full name of responsible person
Soheila Pirdadeh Beiranvand
Street address
Department of midwifery, faculty of nursing and midwifery, Pardis Medical Campus, Kamalvand, Khorramabad, Lorestan, Iran
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Information Technology
Full name of responsible person
Soheila Pirdadeh Beiranvand
Street address
Razi st, Enghelab Avenue, Khorramabad, Lorestan, Iran
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Information Technology
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
Lorestan Unuversity of Medical Sciences
Full name of responsible person
Soheila Pirdadeh Beiranvand
Position
MS. of midwifery
Other areas of specialty/work
Street address
Department of midwifery, faculty of nursing and midwifery, pardis medical campus, kamalvand, Khorramabad,Lorestan,Iran
City
Khorramabad
Postal code
381351698
Phone
+98 66 1322 9095
Fax
+98 66 1620 0140
Email
kimia_n72@yahoo.coms.pirdadeh@lums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Soheila Pirdadeh Beiranvand
Position
MS. of midwifery
Other areas of specialty/work
Street address
Department of midwifery, faculty of nursing and midwifery, pardis medical campus, kamalvand, Khorramabad, Lorestan, Iran
City
Khorramabad
Postal code
381351698
Phone
+98 66 1322 9095
Fax
+98 66 1620 0140
Email
kimia_n72@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Soheila Pirdadeh Beiranvand
Position
MS. of midwifery
Other areas of specialty/work
Street address
Department of midwifery, faculty of nursing and midwifery, pardis medical campus, kamalvand, Khorramabad, Lorestan, Iran
City
Khorramabad
Postal code
381351698
Phone
+98 66 1322 9095
Fax
+98 66 1620 0140
Email
kimia_n72@yahoo.com
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
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