The aim of this study is to compare the effect of Plantago syrup with mefenamic acid capsule on hypermenorrhagia.In this study, women between the ages of 36 and 45 have a normal gynecology examination and healthy pap smear and have menstrual bleeding of more than 7 days or 80 cc per month.People who have potential side effects or require surgical intervention are excluded. The sample size is 68,Based on random assignment divided into two groups of 34 people.The probable time to reach this sample size is one year.In a group of Plantago syrup, in the first 5 days of the menstrual cycle, 5 cc is given every 8 hours with the placebo capsule every 8 hours and In the other group, Mefenamic acid capsule will be given every 8 hours in the first 5 days of the menstrual period, with a placebo syrup of 5 cc every 8 hours.The duration and severity of menstruation will be measured at baseline and after three periods of menstruation.This is a three-blind study. The therapist, patient and analyzer are not aware of interventional groups and placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061634576N1
Registration date:2017-08-19, 1396/05/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-19, 1396/05/28
Registrant information
Name
Mozhdeh Khodabakhsh
Name of organization / entity
Deputy of Research and Technology of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 3876
Email address
khodabakhshm931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Mashhad University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Plantago Syrup and Mefenamic Acid Capsule Hypermernorrhea
Public title
Comparison of the effect of Plantago Syrup and Mefenamic Acid Capsule Hypermernorrhea
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 36 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University of Science and Technology, Faculty of Science and Technology, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2017-08-03, 1396/05/12
Ethics committee reference number
IR.MUMS.REC.1396.42
Health conditions studied
1
Description of health condition studied
Hymenorrhea
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Severity and duration of menstrual bleeding
Timepoint
Beginning of the study and after three periods
Method of measurement
PBAC chart
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Placebo group Placebo syrup 5 cc every 8 hours with Mefenamic acid capsule is given one every 8 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Ghaem Hospital
Full name of responsible person
Mozhdeh Khodabakhsh
Street address
Taghi Abad square of Ghaem Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Full Description University of Science and Technology, Faculty of Science and Technology, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Mashhad 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
School of Traditional Medicine and Mashhad Supplement
Full name of responsible person
Mozhdeh Khodabakhsh
Position
Traditional Iranian Traditional Medicine
Other areas of specialty/work
Street address
Azadi Square, Faculty of Medicine, Second floor, School of Traditional Medicine
City
Mashhad
Postal code
Phone
+98 51 3882 9279
Fax
Email
khodabakhshm931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohreh Feyz Abady
Position
PhD in Iranian medicine
Other areas of specialty/work
Street address
Park square ferdowsi University Faculty of Traditional and Applied Medicine
City
Mashhad
Postal code
Phone
+98 51 3882 9279
Fax
Email
feyzabadiZ@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine and Supplement
Full name of responsible person
Mozhdeh Khodabakhsh
Position
Assistant Professor of Iranian Medicine
Other areas of specialty/work
Street address
Park square ferdowsi University Faculty of Traditional and Applied Medicine
City
Mashhad
Postal code
Phone
+98 51 3882 9279
Fax
Email
khodabakhshm931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)