Protocol summary
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Study aim
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Determination of the effect of Capsella bursa-pastoris on the amount and duration of uterine bleeding in patients with uterine leiomyoma.
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Design
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This study is double-blind, placebo-controlled, randomized clinical trial with a parallel group design of 47 patients which are randomized with block method.
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Settings and conduct
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The site of this 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. Patients during 3 consecutive cycles, take the medication every day 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 for both groups have been investigated before and after treatment, and compared.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: women 18 to 50 years old with menometrorrhagia and uterine leiomyoma without systemic disease; Non-use of any effective medication on menstrual bleeding; Non-use of hormone, anti-fibrinolytic or systemic glucocorticoid; Non-use of Monoamine oxidase inhibitors, Non-use of herbal remedy during the 2 weeks before the study; Having no abnormal pap smear; no pregnancy; no breast feeding. Exclusion criteria: incidence of surgical indications; unwilling to continue participation in the study; incidence of side-effects requiring special treatment.
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Intervention groups
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The intervention group is treated with 500 mg capsules containing a Capsella bursa-pastoris extract and starch, twice a day. The control group will receive 500 mg of capsules containing starch, twice a day.
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Main outcome variables
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Menstrual bleeding, Menstrual bleeding days, Quality of life
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161226031582N1
Registration date:
2018-01-11, 1396/10/21
Registration timing:
prospective
Last update:
2019-05-12, 1398/02/22
Update count:
1
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Registration date
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2018-01-11, 1396/10/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-12-22, 1396/10/01
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Expected recruitment end date
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2018-12-22, 1397/10/01
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Actual recruitment start date
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2018-02-05, 1396/11/16
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Actual recruitment end date
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2019-01-21, 1397/11/01
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Trial completion date
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2019-04-27, 1398/02/07
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Scientific title
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Comparison of Capsella bursa-pastoris with placebo in Menometrorrhagia and quality of life in patients with uterine leiomyoma.
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Public title
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Effect of Capsella bursa-pastoris with placebo on abnormal uterine bleeding and quality of life in patients with uterine leiomyoma.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
120
Actual sample size reached:
47
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-31, 1396/08/09
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Ethics committee reference number
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IR.MUQ.QEC.1396.110
Health conditions studied
1
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Description of health condition studied
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Menometrorrhagia
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ICD-10 code
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N92.0
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ICD-10 code description
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Excessive and frequent menstruation with regular cycle
Primary outcomes
1
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Description
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Amount of Menstrual bleeding
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Timepoint
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One month before, first, second and third month after intervention
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Method of measurement
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Higam Chart
2
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Description
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Duration of Menstrual bleeding
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Timepoint
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One month before, first, second and third month after intervention
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Method of measurement
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Calendar
3
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Description
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Quality of life
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Timepoint
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Before and 3 months after intervention
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Method of measurement
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Menorrhagia questionnaire
Secondary outcomes
1
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Description
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size of uterine leiomyoma
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Timepoint
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Before and 3 months after intervention
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Method of measurement
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Ultrasound
2
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Description
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Side effects of medication
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Timepoint
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3 months after intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ghoum University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Deidentified Individual Participant Data Set: primary and secondary outcome measure only, study Protocol, informed consent form, clinical study report.
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When the data will become available and for how long
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Start the access period 6 months after printing the results.
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To whom data/document is available
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For researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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For academic use and sent by academic mail.
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From where data/document is obtainable
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Contact me by email.
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What processes are involved for a request to access data/document
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To the request sent to me by academic mail,the documentation will be emailed as soon as possible.
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Comments
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