This study aimed to determine the effect of Myrtle fruit syrup on the excessive uterine bleeding. This study is a randomized double blind clinical trial with negative control (placebo) and multicenter. We will include patients 20-55 years of age with excessive and prolonged vaginal bleeding who are enrolled in Mostafa Khomeini hospital and Jamee Zanan(Mirza kpchak-khan) hospital as well as traditional medicine clinics. Inclusion criteria: Endometrial thickness in ultrasound is normal; Gynecologic examination is normal; The Pap smear is normal; concurrent hormonal therapy, herbal and other medicinal plants are not used; there is no chronic disease like diabetes, lupus and thyroid problems; there is no organic disease such as uterus or ovaries or other malignancies; Bleeding is more than 7 days and or Course is less than 21 days. Exclusion criteria: use of hormonal drugs in the study; Use of mefenamic acid in the study; Patients who require surgical intervention and have the other; bleeding during the study is so severe that emergency action is required. 15 patients will receive Myrtle fruit syrup and 15 will receive placebo. Syrup (drug and placebo) is used 3 times daily for a week starting menstruation and 1 tablespoon each half hour after a meal. The trend for 3 menstrual cycles (every month for 7 days) is repeated. Primary outcome: duration of menstruation and intensity of menstrual bleeding in each menstrual cycle is measured with the question of the number of pads used and the amount of hemoglobin before and end of the study are measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109077511N1
Registration date:2012-03-21, 1391/01/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-21, 1391/01/02
Registrant information
Name
Marzieh Qaraaty
Name of organization / entity
Golestan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 1065
Email address
gharaaty1387@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical Faculty of Shahed University
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-08-20, 1392/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the Effect of Myrtus Communis L. (Myrtle) fruit syrup (B 438 syrup) in hypermenorrhea
Public title
The Effect of Myrtus Communis L. fruit syrup in women bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient satisfaction; outpatients aged 20- 55 years with excessive uterine bleeding that have a negative pregnancy test and they are not lactating; Endometrial thickness in ultrasound is normal; Gynecologic examination is normal; The Pap smear is normal; concurrent hormonal therapy, herbal and other medicinal plants are not used; there are no chronic disease like diabetes, lupus and thyroid problems; there is no organic disease such as uterus or ovaries or other malignancies; Intramural fibroids larger than 5 cm sub mucosal or not; Bleeding is more than 7 days and or Course is less than 21 days. Exclusion criteria: use of hormonal drugs in the study; Use of mefenamic acid in the study; Patients who are experiencing possible side effects; Patients who require surgical intervention and have the other; Patients with a personal request to withdraw from the study; bleeding during the study is so severe that emergency action is required.
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical faculty of Shahed university
Street address
Abdollahzade St. Keshavarz blvd.
City
Tehran
Postal code
Approval date
2012-03-06, 1390/12/16
Ethics committee reference number
41/138342
Health conditions studied
1
Description of health condition studied
hypermenorrhea
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Menstrual period duration
Timepoint
at the end of each cycle
Method of measurement
Questionnaire
2
Description
Intensity of menstrual bleeding
Timepoint
at the end of each cycle
Method of measurement
Questionnaire
3
Description
Hemoglobin
Timepoint
before & after the study
Method of measurement
cell counter
Secondary outcomes
1
Description
drug side effect
Timepoint
at the end of study
Method of measurement
questionniare
Intervention groups
1
Description
Syrup (drug), 3 times daily for a week starting menstruation, 1 tablespoon each half hour after meal. The trend for 3 menstrual cycles (every month for 7 days) is repeated.
Category
Treatment - Drugs
2
Description
Syrup (placebo), 3 times daily for a week starting menstruation, 1 tablespoon each half hour after meal. The trend for 3 menstrual cycles (every month for 7 days) is repeated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa khomeini hospital
Full name of responsible person
Street address
Italy St, khKeshavarz blvd
City
Tehran
2
Recruitment center
Name of recruitment center
traditional iranian medicine salamatgah, shahed university of medical science
Full name of responsible person
Street address
17,th. third dashtestan.Dr shariati St.
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical faulty, Shahed University
Full name of responsible person
Dr. Heshmati
Street address
Abdollahzadeh st, Keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?