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Evaluation of the effect of roasted lentil flour in heavy menstrual bleeding and quality of life in comparison with tranexamic acid in women suffering from menorrhagia

Protocol summary

Summary
Menorrhagia refers to menstrual bleeding more than 80 cc per cycle or a period more than 7 days which half of the cases don't have a pathological cause. In this study, which is a randomized clinical trial, the purpose is to compare the effect of roasted lentil flour as a traditional medicine product with tranexamic acid on the amount of menstrual bleeding. In this study 50 women suffering from menorrhagia aged 18-55 and having at least 100 score in pictorial blood loss and having the inclusion criteria, after initial ultrasonography and lab tests (Hb, PT, PTT, TSH, Prolactin) and satisfaction, randomly divided into intervention and control groups. The intervention group is treated with roasted lentil flour in the form of 10 gram sachets. fasting morning 3 sachets from the beginning of the menstrual bleeding to at last 7 days. The control group is given 500 mg tranexamic acid every 8 hours for a duration of 7 days starting from the first day of menstrual bleeding. Patients during 3 consecutive cycles, take the medication and fill up Pictorial blood assessment chart. At the end, the amount of bleeding, the duration of menstruation and the number of the used pads and also quality of life and HB for both groups have been investigated before and after treatment, and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072935363N1
Registration date: 2017-09-19, 1396/06/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Malihe Shafiei
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 37707843
Email address
mshafiei@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Qom University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of roasted lentil flour in heavy menstrual bleeding and quality of life in comparison with tranexamic acid in women suffering from menorrhagia
Public title
The comparison of the effect of roasted lentil flour and tranexamic acid on the amount of menstrual bleeding and quality of life in women suffering from heavy menstrual bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Regular menstrual cycle ; Having a score more than 100 in Pictorial blood assessment chart ; Age between 18 to 55 years old ; No abnormal pap smear or ultrasonography ; No systemic disease (Thyroid, Hyperprolactinemia, Coagulopathy, Diabetes) ; No organic diseases such as uterine or ovary disease or other malignancies ; No consumption of drugs that effect on amount of menstrual bleeding (OCP, ASA) since 2 months ; No pregnancy. Exclusion criteria: Unwilling to continue participation in the study ; Incidence of side-effects requiring special treatment ; The use of any hormonal or contraceptive drug during the study ; Pregnancy.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethical Committee of Qom University of Medical Sciences
Street address
Plaque 83, 4th Alley, 1/1 Lane, Safashar Street, Qom
City
Qom
Postal code
87366-37169
Approval date
2017-07-11, 1396/04/20
Ethics committee reference number
IR.MUQ.QEC.1396.43

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
Amount of bleeding
Timepoint
One month before, first, second and third month after intervention
Method of measurement
Higam Chart

2

Description
Duration of bleeding
Timepoint
One month before, first, second and third month after intervention
Method of measurement
Higam Chart

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and 3 months after intervention
Method of measurement
Menorrhagia questionnaire

2

Description
Hb level
Timepoint
Before and 3 months after intervention
Method of measurement
Lab test

Intervention groups

1

Description
Intervention group is treated with roasted lentil flour in the form of 10 gram sachets, fasting morning 3 sachets from the beginning of the menstrual bleeding to 7 days.
Category
Treatment - Drugs

2

Description
Control group is given two 250 mg tranexamic acid capsule every 8 hours from the beginning of the menstrual bleeding to 7 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Zafar Clinic
Full name of responsible person
Dr. Shafiei
Street address
Zafar's bulding, 7thTir Street, Shahrdari Square, Qom
City
Qom

2

Recruitment center
Name of recruitment center
Izadi Hospital
Full name of responsible person
Dr. shafiei
Street address
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr. Majid Asghari
Street address
No 83 Plaque, 4th Alley, 1/1 Alley, Safashahr Street, Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Qom University of Medical Sciences
Full name of responsible person
Dr. Malihe Shafiei
Position
Resident of Traditional Medicine
Other areas of specialty/work
Street address
Saheli street, School of Traditional Medicine, Qom University of Medical Sciences
City
Qom
Postal code
Phone
+98 25 3770 7843
Fax
Email
mshafiei@muq.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr. Fateme Nojavan
Position
PHD Traditional Medicine
Other areas of specialty/work
Street address
Saheli Street, School of Traditional Medicine, Qom University of Medical Sciences
City
Qom
Postal code
Phone
+98 25 3770 7843
Fax
Email
nojavan.f@tak.iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr. Malihe Shafiei
Position
Resident of Traditional Medicine
Other areas of specialty/work
Street address
Saheli street, School of Traditional Medicine, Qom University of Medical Sciences
City
Qom
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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