Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
105
105
empty
2018-06-22, 1397/04/01
2018-06-22 00:00:00
empty
2019-02-14, 1397/11/25
2019-02-14 00:00:00
empty
2019-07-11, 1398/04/20
2019-07-11 00:00:00
empty
Adding the recriument and trial completion dates
Adding the recriument and trial completion dates
empty
افزودن تاریخ شروع و اتمام نمومه گیری و کارآزمایی بالینی
افزودن تاریخ شروع و اتمام نمومه گیری و کارآزمایی بالینی
Protocol summary
Study aim
Comparison and determination of the effect of Citrus Aurantium extract, Mefenamic acid and placebo capsules on the severity of primary dysmenorrhea
Design
Double-blind clinical trial with parallel and randomized blocking in 3 groups of each 35 sample
Settings and conduct
This study is a double-blind(participants and researcher) clinical trial with parallel and randomized blocking groups.After obtaining permission from the Ethics Committee of Tabriz University of Medical Science,the study will be performed in three groups, each of 35 eligible participants with moderate to severe dysmenorrhea from three selected high schools in Tabriz, unaware of eachother.Each group will recieve 250 mg capsule of Citrus aurantium extract or Mefenamic acid or Placebo randomly for the first three days of each period.They will mark their pain intensity on the McGill pain Scale and complete other relevant questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being single-Age from 15 to 20- Primary Dysmenorrhea with moderate to severe intensity- Regular distance between cycles- No history of abdominal or pelvic surgery- No irritation, burning or abnormal vaginal secretions- No history of pelvic inflammatory disease,Endometriosis,Myoma and tumor- No stressful situations like death of first degree relatives, seperation of parents,... in the last 6 months.Exclusion criteria: Unwillingness to use medicine due to severe side effects or discontent-Use of any medicine or herb-Allergy to Citrus aurantium
Intervention groups
Citrus Aurantium extract capsule group
Mefenamic Acid capsule group
Placebo capsule group
Main outcome variables
Citrus aurantium group -Mefenamic Acid group -Placebo group
Severity of Primary Dysmenorrhea- Age of the menarche -Age
The distance between two cycles -Number of bleeding days-Physical activity-Complications of intervention- Father's education-Mother's education
General information
Reason for update
Adding the recriument and trial completion dates
Acronym
IRCT registration information
IRCT registration number:IRCT20180524039815N1
Registration date:2018-05-31, 1397/03/10
Registration timing:prospective
Last update:2021-04-11, 1400/01/22
Update count:1
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Farkhondeh Aboualsoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3331 0477
Email address
Abolsoltanif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2019-02-14, 1397/11/25
Trial completion date
2019-07-11, 1398/04/20
Scientific title
Comparison of the effect of Citrus Aurantium extract with Mefenamic Acid on the intensity of Primary Dismenorrhea
Public title
Effect of Citrus Aurantium extract on painful menstruation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being single-Age from 15 to 20 Having Primary Dysmenorrhea with moderate to severe intensity accourding to Mcgill pain scale atleast for the last cycle Regular distance between menstrual cycles No previous abdominal or pelvic surgery No symptomes like irritation, burning or abnormal vaginal secretions No past history of pelvic inflammatory disease,Endometriosis,Myoma and tumor No stressful situations like death of first degree relatives, seperation of parents,... in the last 6 months.
Exclusion criteria:
Unwillingness to take medication for different reasons like severe side effects or discontent Using any medicine or herbal product Being allergic to Citrus Aurantium flower.
Age
From 15 years old to 20 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
105
Actual sample size reached:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Initially the qualified participants will be asked to fill the individual, demoghraphic,menstrual and visual pain scale questionnaires one month before beginning of the medications(Citrus Aurantium extract,Mefenamic Acid,Placebo) and in the first three days of the cycle.
Randomization will be based on Fixed size block randomization. In selection of blocks random numbers table will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
250 mg capsules containing Citrus Aurantium extract or Mefenamic Acid or Placebo(Starch) which are similar in shape, color, size and aroma, are made at Tabriz Faculty of Pharmacy and Tabriz Medical Science Research and Development Center. They are placed in the envelopes A, B and C by the pharmacist. Each code indicates that there is one type of capsule inside the envelope. The researcher will randomly distribute the envelopes among eligible participants in the study. َApart from the pharmacist, investigator or participants, will be unaware of the envelopes content. The researcher will not know which of the participants will use the envelope A or the envelope B or the envelope C. The type of the medicines inside the envelopes will not be obvious to the researcher and participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah Ave, Pharmacy Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.TBZMED.REC.1397.105
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
Intensity of Dysmenorrhea
Timepoint
Monthly
Method of measurement
Visual Analogue Scale(VAS) - Mcgill pain scale
2
Description
Days of bleeding
Timepoint
Daily
Method of measurement
Questionnaire
3
Description
Distance between two cycles
Timepoint
Day
Method of measurement
Questionnaire
4
Description
Physical activity
Timepoint
Monthly
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Complications of interventions
Timepoint
During intervention
Method of measurement
Questionnaire-Report-Observation
Intervention groups
1
Description
Intervention group: Citrus Aurantium extract 250 mg capsule every 8 hours during the first three days of the cycle
Category
Treatment - Drugs
2
Description
Intervention group: Mefenamic Acid 250 mg capsule every 8 hours during the first three days of the cycle
Category
Treatment - Drugs
3
Description
Intervention group: Placebo 250 mg capsule(containing starch) every 8 hours during the first three days of the cycle
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nokhbegan mandeghar private High school
Full name of responsible person
Farkhondeh Aboualsoltani
Street address
Saadi Shomali Ave, Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5158493390
Phone
+98 41 3333 1003
Email
far_absl@yahoo.com
2
Recruitment center
Name of recruitment center
Gholdis private High school
Full name of responsible person
Farkhondeh Aboualsoltani
Street address
Parvin etesami Ave. Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5158493390
Phone
+98 41 3331 0477
Email
far_absl@yahoo.com
3
Recruitment center
Name of recruitment center
Enghelab e Eslami High school
Full name of responsible person
Farkhondeh Aboualsoltani
Street address
Parvin etesami Ave, Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5158493390
Phone
+98 41 3330 8620
Email
far_absl@yahoo.com
4
Recruitment center
Name of recruitment center
Peik Saadat private High school
Full name of responsible person
Farkhondeh Aboualsoltani
Street address
Nezami Ave, Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5159813346
Phone
+98 41 3332 0357
Email
far_absl@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
No.2 Central building,Tabriz University of Medical Sciences,Gholgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parvin Bastani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rah Ahan Ave. Taleghani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5158493390
Phone
+98 41 3331 0477
Email
Bastani.parvin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farkhondeh Aboualsoltani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional Medicine Faculty,Tabriz University of Medical Sciences,Gholgasht St, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5158493390
Phone
+98 41 3331 0477
Email
far_absl@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farkhondeh Aboualsoltani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
آدرس خیابان Traditional Medicine Faculty,Tabriz University of Medical Sciences,Gholgasht St, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5158493390
Phone
+98 41 3331 0477
Email
far_absl@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual information is publicable after making unrecognisable
When the data will become available and for how long
Access is provided 2 months after publication of the results
To whom data/document is available
Researchers may ask for data of the study
Under which criteria data/document could be used
Statistical analysis on data and assesing prevalance is permitted
From where data/document is obtainable
The following address may be used for requesting information:
Far_absl@yahoo.com
What processes are involved for a request to access data/document
After contacting the mentioned address and evaluation of the request, answer will be provided in two weeks