Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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IRCT |
Last refreshed on:
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22 February 2018 |
Main ID: |
IRCT2017061634576N1 |
Date of registration:
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2017-08-19 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Comparison of the effect of Plantago Syrup and Mefenamic Acid Capsule Hypermernorrhea
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Scientific title:
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Comparison of the effect of Plantago Syrup and Mefenamic Acid Capsule Hypermernorrhea |
Date of first enrolment:
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2017-09-23 |
Target sample size:
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68 |
Recruitment status: |
Recruiting |
URL:
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http://en.irct.ir/trial/26390 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Zohreh Feyz Abady
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Address:
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Park square ferdowsi University Faculty of Traditional and Applied Medicine
Mashhad
Iran (Islamic Republic of) |
Telephone:
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+98 51 3882 9279 |
Email:
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feyzabadiZ@mums.ac.ir |
Affiliation:
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Mashhad University of Medical Sciences |
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Name:
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Mozhdeh Khodabakhsh
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Address:
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Azadi Square, Faculty of Medicine, Second floor, School of Traditional Medicine
Mashhad
Iran (Islamic Republic of) |
Telephone:
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+98 51 3882 9279 |
Email:
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khodabakhshm931@mums.ac.ir |
Affiliation:
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School of Traditional Medicine and Mashhad Supplement |
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Key inclusion & exclusion criteria
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Inclusion criteria: Criteria for entering the study of outpatients between the ages of 36-45 years with a complaint of hypernorrhoea that have negative pregnancy tests and not being breast-fed;The patient has no desire for hormonal treatment (ocp);Genic examination is normal;Pap smear sample of the patient is healthy;At the same time as hormonal treatments,Not use to other Herbal remedies and herbs; A month before entering in to the study,Doesn't use any drug to heal much hemorrhage;Use non-hormonal prevention;Hb is between 11 and 14;A patient with diabetes,Does not have uncontrolled blood pressure, congestive heart disease, and blood dislocations;The patient has no history of chronic diseases such as lupus and thyroid problems;The patient does not have a history of uterine malformations, ovaries, or other malignancies;Patient does not have hyperlichotheneemia ;Does not have IUD;The BMI is between 18/5 and 30;No fibroma.Exit criteria for patients who get pregnant during the study;Patients who use hormonal drugs during the study;Patients with possible side effects;Patients who require other interventions and have surgery;Patients who decide to leave the study with a personal request;The bleeding during the study is so severe that it requires emergency procedures.
Exclusion criteria:
Age minimum:
36 years
Age maximum:
45 years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hymenorrhea. Excessive and frequent menstruation with regular cycle
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Excessive and frequent menstruation with regular cycle
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Intervention(s)
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There are two intervention groups in the study group. The serum of Barragon syrup is given at 5 cc every 8 hours in the first 5 days of menstruation. In the other group, the muscle capsule is given every 8 hours once in the first 5 days of menstruation.
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Placebo group Placebo syrup 5 cc every 8 hours with Mefenamic acid capsule is given one every 8 hours.
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Intervention 1: There are two intervention groups in the study group. The serum of Barragon syrup is given at 5 cc every 8 hours in the first 5 days of menstruation. In the other group, the muscle capsule is given every 8 hours once in the first 5 days of menstruation. Intervention 2: Placebo group Placebo syrup 5 cc every 8 hours with Mefenamic acid capsule is given one every 8 hours.
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Placebo
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Treatment - Drugs
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Primary Outcome(s)
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Severity and duration of menstrual bleeding. Timepoint: Beginning of the study and after three periods. Method of measurement: PBAC chart.
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Source(s) of Monetary Support
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Deputy of Research and Technology of Mashhad University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Mashhad University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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