1-Determination of the effect of Capsella bursa-pastoris on the amount of uterine bleeding in patients with uterine leiomyoma
2-Determining the effect of Capsella bursa-pastoris on the number of uterine bleeding days in patients with uterine leiomyoma
3-- Determination of the effect of Capsella bursa-pastorison the quality of life of patients with uterine leiomyoma
Design
In this research,120 eligible woman with menometrorrhagia and uterine leiomyoma were chosen and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
leiomyoma are the most common diseases of women that abnormal uterine bleeding is the most common symptom of them.The aim of this study was to evaluate the effect of Capsella bursa-pastoris on uterine bleeding in patients with uterine leiomyoma.The site of the study is the Persian Medicine Clinic and the Women's Clinic of Foroghani Hospital in Qom.In this double-blind study, the patient and the investigator will not be aware of the nature of prescribing drugs.The intervention group is treated with extracts of Capsella bursa-pastoris in the form of three capsules of 500 mg at meal intervals, and in the control group, instead of the Capsella bursa-pastoris capsules,placebo of capsella bursa pastoris is prescribed in the same order.Patients during 3 consecutive cycles, take the medication everyday 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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women Have a score more than 100 in pictorial blood assessment chart; age between 18 to 50 years old; the existence of uterine leiomyoma proven in ultrasound; no use of any effective medication on menstrual bleeding (such as 0CP, ASA, anti-coagulant); no regular use of special herbal remedy during the 2 weeks before the study; no systemic disease (Thyroid, Hyperprolactinemia, Coagulopathy, hemoglobinopathy); no abnormal pap smear; no pregnancy; no breast feeding. Exclusion criteria: incidence of surgical indications such as: abnormal bleeding disorder of vital signs, resistant anemia to usual treatments, severe anemia (hemoglobin below 7), acute pain, severe urinary symptoms or hydronephrosis; the use of any hormone, anti-fibrinolytic or systemic glucocorticoid; the use of Monoamine oxidase inhibitors; allergy to the drug studied; pregnancy during the study; unwilling to continue participation in the study; incidence of side-effects requiring special treatment.
Intervention groups
The intervention group is treated with 500 mg capsules containing a Capsella bursa-pastoris extract and starch, three times a day, between meals at 10:00 am, 5 am and before bedtime for three months.
The control group will receive 500 mg ofcapsules containing starch, three times a day between meals at 10:00 am, 5 am and before bedtime for three months.
Main outcome variables
Menstrual bleeding, Menstrual bleeding days, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161226031582N1
Registration date:2018-01-11, 1396/10/21
Registration timing:registered_while_recruiting
Last update:2018-01-11, 1396/10/21
Update count:1
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Atieh sadat Danesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3293 8506
Email address
atiehsdanesh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Capsella bursa-pastoris with placebo in Menometrorrhagia and quality of life in patients with uterine leiomyoma.
Public title
Effect of Capsella bursa-pastoris with placebo on abnormal uterine bleeding and quality of life in patients with uterine leiomyoma.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a score more than 100 in Pictorial blood assessment chart
Age between 18 to 50 years old
The existence of uterine leiomyoma proven in ultrasound
No use of any effective medication on menstrual bleeding such as: 0CP, ASA, anti-coagulant
No regular use of special herbal remedy during the 2 weeks before the study
No systemic disease such as :Thyroid, Hyperprolactinemia, Coagulopathy, hemoglobinopathy
No abnormal pap smear
No pregnancy
No breast feeding
Exclusion criteria:
Incidence of surgical indications such as: abnormal bleeding disorder of vital signs, resistant anemia to usual treatments, severe anemia (hemoglobin below 7), acute pain, severe urinary symptoms or hydronephrosis
The use of any hormone, anti-fibrinolytic or systemic glucocorticoid
The use of Monoamine oxidase inhibitors
allergy to the drug studied
Pregnancy during the study
Unwilling to continue participation in the study
Incidence of side-effects requiring special treatment
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of patients to the two groups is based on the block method. The size of block 4 is considered. So there are six quadruple blocks, including AABB, ABAB, BBAA, BABA, ABBA, BAAB. Selection of each block will also be a crash and will be done using dice throwing. According to the sample size of 120 and the fourth block, at least 30 blocks are required.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted double-blinded.For this purpose, patients and the investigator will not be aware of the nature of prescribing drugs. For this purpose, each participant is given code at the beginning of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Qom University of Medical Sciences
Street address
Plaque 83, 4th Alley, 1/1 Lane, Safashar Street
City
Qom
Province
Ghoum
Postal code
87366-37169
Approval date
2017-10-31, 1396/08/09
Ethics committee reference number
IR.MUQ.QEC.1396.110
Health conditions studied
1
Description of health condition studied
Menometrorrhagia
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Amount of Menstrual bleeding
Timepoint
One month before, first, second and third month after intervention
Method of measurement
Higam Chart
2
Description
Duration of Menstrual bleeding
Timepoint
One month before, first, second and third month after intervention
Method of measurement
Calendar
3
Description
Quality of life
Timepoint
Before and 3 months after intervention
Method of measurement
Menorrhagia questionnaire
Secondary outcomes
1
Description
size of uterine leiomyoma
Timepoint
Before and 3 months after intervention
Method of measurement
Ultrasound
2
Description
Side effects of medication
Timepoint
3 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Treated with 500mg capsules containing Capsella bursa-pastoris extract and starch, they will be placed three times a day between meals at 10am, 5am and will sleep for three months before bedtime.
Category
Treatment - Drugs
2
Description
Control group:The control group will receive 500 mg ofcapsules containing starch, three times a day between meals at 10:00 am, 5 am and before bedtime for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zafar clinic
Full name of responsible person
Atiehsadat Danesh
Street address
Zafar's bulding, 7thTir Street, Shahrdari Square
City
Qom
Province
Ghoum
Postal code
3718673364
Phone
+98 25 3660 2915
Email
atiehsdanesh@gmail.com
2
Recruitment center
Name of recruitment center
Women's Clinic of Forghani Hospital
Full name of responsible person
Atiehsadat Danesh
Street address
Forghani Hospital,Zafar Street
City
Qom
Province
Ghoum
Postal code
37158733
Phone
+98 25 3333 8208
Email
atiehsdanesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr Hossein Saghafi
Street address
No. 83,Alley 1/1, Alley 4,Safashahr Street,Deputy of Research of Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2740
Email
atiehsdanesh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Atiehsadat Danesh
Position
consultant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Saheli Street,School of Persian medicine
City
Qom
Province
Ghoum
Postal code
3719657189
Phone
+98 25 3770 7843
Email
atiehsdanesh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr Fatemeh Nojavan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Saheli Street,School of Persian medicine
City
Qom
Province
Ghoum
Postal code
3719657189
Phone
+98 25 3770 7843
Email
Mapn2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Atiehsadat Danesh
Position
consultant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Saheli Street,School of Persian medicine
City
Qom
Province
Ghoum
Postal code
3719657189
Phone
+98 25 3770 7843
Fax
Email
atiehsdanesh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Deidentified Individual Participant Data Set: primary and secondary outcome measure only, study Protocol, informed consent form, clinical study report.
When the data will become available and for how long
Start the access period 6 months after printing the results.
To whom data/document is available
For researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For academic use and sent by academic mail.
From where data/document is obtainable
Contact me by email.
What processes are involved for a request to access data/document
To the request sent to me by academic mail,the documentation will be emailed as soon as possible.