Protocol summary
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Study aim
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Comparison and determination of the effect of Citrus Aurantium extract, Mefenamic acid and placebo capsules on the severity of primary dysmenorrhea
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Design
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Double-blind clinical trial with parallel and randomized blocking in 3 groups of each 35 sample
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Citrus Aurantium extract capsule group
Mefenamic Acid capsule group
Placebo capsule group
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Main outcome variables
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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
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Reason for update
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Adding the recriument and trial completion dates
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Acronym
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IRCT registration information
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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
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Registration date
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2018-05-31, 1397/03/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-22, 1397/04/01
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Expected recruitment end date
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2018-10-23, 1397/08/01
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Actual recruitment start date
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2018-06-22, 1397/04/01
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Actual recruitment end date
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2019-02-14, 1397/11/25
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Trial completion date
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2019-07-11, 1398/04/20
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Scientific title
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Comparison of the effect of Citrus Aurantium extract with Mefenamic Acid on the intensity of Primary Dismenorrhea
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Public title
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Effect of Citrus Aurantium extract on painful menstruation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 15 years old to 20 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
105
Actual sample size reached:
105
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-21, 1397/02/01
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Ethics committee reference number
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IR.TBZMED.REC.1397.105
Health conditions studied
1
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Description of health condition studied
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Primary Dysmenorrhea
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ICD-10 code
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N94.4
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ICD-10 code description
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Primary dysmenorrhea
Primary outcomes
1
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Description
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Intensity of Dysmenorrhea
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Timepoint
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Monthly
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Method of measurement
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Visual Analogue Scale(VAS) - Mcgill pain scale
2
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Description
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Days of bleeding
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Timepoint
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Daily
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Method of measurement
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Questionnaire
3
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Description
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Distance between two cycles
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Timepoint
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Day
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Method of measurement
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Questionnaire
4
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Description
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Physical activity
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Timepoint
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Monthly
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Complications of interventions
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Timepoint
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During intervention
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Method of measurement
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Questionnaire-Report-Observation
Intervention groups
1
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Description
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Intervention group: Citrus Aurantium extract 250 mg capsule every 8 hours during the first three days of the cycle
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Mefenamic Acid 250 mg capsule every 8 hours during the first three days of the cycle
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Placebo 250 mg capsule(containing starch) every 8 hours during the first three days of the cycle
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Deputy of Research of Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Individual information is publicable after making unrecognisable
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When the data will become available and for how long
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Access is provided 2 months after publication of the results
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To whom data/document is available
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Researchers may ask for data of the study
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Under which criteria data/document could be used
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Statistical analysis on data and assesing prevalance is permitted
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From where data/document is obtainable
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The following address may be used for requesting information:
Far_absl@yahoo.com
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What processes are involved for a request to access data/document
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After contacting the mentioned address and evaluation of the request, answer will be provided in two weeks
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Comments
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