The purpose of this study is to compare the effect of licorice syrup with ibuprofen on moderate to severe primary dysmenorrhea. Here, primary dysmenorrhea will be diagnosed by patients’ medical history and moderate to severe dysmenorrhea will be based on verbal multidimensional scoring system. Our case study will be sixty patients aged between 18-25 years old with no any other known disease and will have entered the study after obtaining consent. Patients will be sampled from the students living in Tehran dormitories or patients referring to traditional medicine clinic of Tehran Imam Khomeini hospital. It is worth mention that, demographic information and history of dysmenorrhea including severity and duration of pain in the last menstrual cycle will be registered before enrolling the study. One of the two groups, enrolled randomly by a computer coding, will have received Ibuprofen 400 mg every 8 hours and placebo syrup and the other will have received Licorice syrup 5 cc 2 times a day and placebo tablets. The patients will have taken the drug from the first day of menstruation to 5th and for two consequent cycles. We will evaluate the primary pain intensity and its changes by visual analogue scale and the duration of pain by hour during the study. Here participants, observers and analysts do not have any information about the patients within the groups. It should be noted that, although the patients are permitted to use Acetaminophen if needed, reporting the dose for ultimate comparison is necessary.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081323610N1
Registration date:2016-02-17, 1394/11/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-17, 1394/11/28
Registrant information
Name
Zahra Jafari
Name of organization / entity
Faculty of Traditional Medicine, Shahid Sadoughei University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 353223891
Email address
z-jafari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research,Shahid sadoughi University of Medical Sciences and Health Services, Yazd
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of licorice syrup on primary dysmenorrhea compared with Ibuprofen
Public title
The effect of licorice syrup on dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Aged between 18-25 years; Moderate and severe dysmenorrhea (grade 2, 3) based on Verbal Multidimensional Scoring System; Regular menstrual cycles (every 21-35 days and bleeding 3 to 10 days for at least three recent cycles).
Exclusion criteria: Pelvic pathology (including Endometriosis, Adenomyosis, Fibroids, Ovarian Cysts, Pelvic Inflammatory Disease, etc); Known diseases (including Chronic Hepatitis, Cholestatic Liver Disease, Cirrhosis, Severe Renal Insufficiency, Diabetes Mellitus, Arrhythmias, Hypertension, Hypertonia and Hypokalemia); Existence of stressors (such as loss of a close relative and Intense familial debate) during recent 6 months; History of allergy to licorice; Concurrent use of other products containing licorice; Taking another painkiller that is not defined in the study; Concomitant use of OCP; Drug intolerance; Lack of desire to continue the treatment for any reason; Another disease that will have required medical treatment during the study.
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The mentioned scientific name has been registered unchanged as approved by the University Research Council.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Central department of Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Sq.
City
Yazd
Postal code
8916978477
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
IR.SSU.REC.1394.121
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Pain intensity
Timepoint
Before intervention- Every day during intervention
Method of measurement
Visual Analogue Scale(VAS)
2
Description
Pain duration
Timepoint
Before intervention- Every day during intervention
Method of measurement
hour
Secondary outcomes
1
Description
adverse effect of licorice syrup
Timepoint
At the end of each cycle of intervention
Method of measurement
Questionnaire
2
Description
adverse effect of Ibuprofen such as Nausea, dyspepsia, vomiting, ulcers and gastrointestinal bleeding
Timepoint
At the end of each cycle of intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention Group: licorice syrup at a dose of 5 mL twice daily and placebo every 8 hours during the first five days of each cycle and for two consecutive cycles
Category
Treatment - Drugs
2
Description
Control Group: Ibuprofen 400 mg every 8 hours and 5 ml of placebo syrup twice a day, during the first five days of each cycle and for two consecutive cycles
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional medicine clinic of Imam Khomeini hospital
Full name of responsible person
zahra jafari
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ezoddini
Street address
Central department of Shahid Sadoughei Medical University, Shahid Bahonar Sq.
City
Yazd
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, Shahid Sadoughei 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
Faculty of Traditional Medicine, Shahid Sadoughei University of Medical Sciences, Ardakan, Yazd
Full name of responsible person
zahra jafari
Position
Phd student of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Imam Khomeini Ave.
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
Email
z-jafari@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Traditional Medicine, Shahid Sadoughei University of Medical Sciences, Ardakan, Yazd
Full name of responsible person
Dr. Majid Emtiazy
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Ave.
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
Email
Dr.emtiazy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine, Shahid Sadoughei University of Medical Sciences, Ardakan, Yazd
Full name of responsible person
Zahra Jafari
Position
PhD student of Traditional Medicine
Other areas of specialty/work
Street address
Imam Khomeini Ave.
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
Email
z-jafari@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)