Protocol summary

Summary
This double-blind randomized clinical trial will be conducted to assess the effect of Licorice on premenstrual symptoms. The study population comprise 84 female students having premenstrual symptoms according to PSST (Premenstrual Symptoms Screening Tool) questionnaire and satisfied the inclusion criteria. The participants will be randomly assigned into Licorice or placebo group. The participants in the intervention group will receive Licorice capsule while participants in the control group will receive placebo with the same dosage. The outcome measures in this study are premenstrual symptoms, as obtained through the PSST questionnaire before and during the intervention. At the end of the study, two premenstrual syndrome sign scores will be obtained for every participant (1 before intervention to recognize the eligible samples and after 2 cycle intervention).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015061722779N1
Registration date: 2015-06-29, 1394/04/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Maryam Farahmand
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 1685
Email address
m-farahmand@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study on the Effects of Licorice compared to placebo on severity of Pre Menstrual Syndrome (PMS) signs among college students
Public title
Effects of Licorice on premenstrual disturbances
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: age 18-35 years; having regular menstrual cycles; experience of PMS symptoms; not smoking; alcohol or drug usage; willingness to participate in the study; completed a written informed consent. Exclusion criteria: pregnancy; lactation; menstrual cycle irregularity; medical disease; hormonal method of contraception; developing tensions and severe psychological crisis within the past 6 months.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd., corner of Ghods St.
City
Tehran
Postal code
Approval date
2015-06-16, 1394/03/26
Ethics committee reference number
IR.TUMS.REC.1394.59

Health conditions studied

1

Description of health condition studied
Pre Menstrual Syndrome (PMS)
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Premenstural syndrome severity
Timepoint
monthly
Method of measurement
Premenstrual Symptoms Screening Tool (PSST) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Oral administration of 110 mg licorice capsule for 2 menstrual cycle 3 times a day
Category
Treatment - Drugs

2

Description
Placebo capsules had 110mg starch with the same shape for 2 menstrual cycle 3 times a day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran dorms
Full name of responsible person
Maryam Farahmand
Street address
Nursing Midwifery Care Research Center, Faculty of Nursing and Midwifery , Nosrat st., Tohid sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Street address
Nursing Midwifery Care Research Center, Faculty of Nursing and Midwifery , Nosrat st., Tohid sq.
City
Tehran
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, Tehran 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
Nursing Midwifery Care Research Center
Full name of responsible person
Reza Negarandeh
Position
Professor/Director
Other areas of specialty/work
Street address
Nursing Midwifery Care Research Center, Faculty of Nursing and Midwifery , Nosrat st., Tohid sq.
City
Tehran
Postal code
Phone
+98 21 6642 1685
Fax
Email
rnegarandeh@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Farahmand
Position
PhD candidate
Other areas of specialty/work
Street address
Nursing Midwifery Care Research Center, Faculty of Nursing and Midwifery , Nosrat st., Tohid sq.
City
Tehran
Postal code
Phone
+66 421685
Fax
Email
m-farahmand@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Negarandeh
Position
PhD/Professor
Other areas of specialty/work
Street address
Keshavarz Blvd., the corner of Ghods St.
City
Tehran
Postal code
Phone
+98 21 6642 1685
Fax
Email
rnegarandeh@tums.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
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