This pilot study (before-after study) will be done after approval of Ethics Committee of Shahid Beheshti University of Medical Sciences. 25 women with menorrhagia referring to gynecological clinic who have regular periods will be studied. At the beginning, written informed consent will be received of all eligible persons. In first visit, Pictorial and quality of life forms will be filled for all patients. Sauce of Quince is prescribed in two menstruation cycles, three teaspoonful after each meal for two months. Sauce of Quince is prepared by the researcher. Patients will be compared in the number days and severity of bleeding before the intervention (the first month of the study) and then the first and second cycle after the intervention. In this study bleeding more than 80 ml, or 8 or more days in each menstrual cycle refers as menorrhagia. Pictorial blood loss assessment chart (PBAC) will be used to diagnosis menorrhagia and determine the amount of bleeding. Based on this chart, score 100 (80 cc) or more is massive bleeding, and bleeding of less than 80 cc will be regarded as patient recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102621937N2
Registration date:2016-11-17, 1395/08/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-17, 1395/08/27
Registrant information
Name
Maryam Bahman
Name of organization / entity
School of Traditional Medicine and Materia Medica Research Center, Shahid Beheshti university of M
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
ma.bahman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of the sauce of Quince on uterine bleeding in women with menorrhagia
Public title
The effects of the sauce of Quince on uterine bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: menorrhagia (menorrhagia diagnosis based on the amount of excessive bleeding (more than 80 cc of blood) based on the charts Pictorial or long-term (greater than or equal 8 days); age 50-18 years old; regular menstrual cycles; severe menstrual bleeding in two consecutive cycles. Exclusion criteria: irregular menstrual periods or menstrual bleeding between periods; presence of uterine fibroid larger than 3 cm; other pathological causes for abnormal bleeding; systemic diseases affecting normal menstrual bleeding; taking any drugs or medications that affect the menstrual hormones; IUD; pregnancy; hemoglobin below 10.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak Street, Shahid Chamran highway
City
Tehran
Postal code
Approval date
2016-08-28, 1395/06/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.375
Health conditions studied
1
Description of health condition studied
Menorrhagia
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Reduction of uterine bleeding
Timepoint
First and second months after intervention
Method of measurement
Pictorial Blood Loss assessment Chart (PBAC)
Secondary outcomes
1
Description
Reduction of menstrual days
Timepoint
First and second months after intervention
Method of measurement
PABC Chart
2
Description
Improving the quality of life
Timepoint
Second month after intervention
Method of measurement
Quality of Life Questionnaire
Intervention groups
1
Description
Having sauce of Quince a teaspoonful after every meal for two months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Private clinic of Mrs. Afruz Mirahi
Full name of responsible person
Afruz Mirahi
Street address
Unit one, Razi complex, South thirty meters Street, Ahvaz, Iran.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Street address
No.8 Shams Alley, Opposite Tavanir Street, Valiasr Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Full name of responsible person
Maryam Bahman
Position
PhD student of Traditional Medicine
Other areas of specialty/work
Street address
No.8, Shams Alley, Opposite Tavanir Street, Valiasr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
dr.bahman98@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Full name of responsible person
Mojgan Tansaz M.D
Position
MD/ PhD
Other areas of specialty/work
Street address
No.8, Shams Alley, Opposite Tavanir Street, Valiasr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
tansaz_mojgan@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Full name of responsible person
Maryam Bahman
Position
PhD student of Traditional Medicine
Other areas of specialty/work
Street address
No.8, Shams Alley, Opposite Tavanir Street, Valiasr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
dr.bahman98@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)