Comparison of the efficacy of capsule of Golnar” and Placebo on heavy menstural bleeding: A double- blind randomized clinical trial
- Conditions
- MENSTURAL BLEEDING.Excessive and frequent menstruation with regular cycle
- Registration Number
- IRCT2017010231722N1
- Lead Sponsor
- Vice chancellor for reaserch, Iran University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 88
• Informed written consent of patients
• Age 40-20 years
• Has bleeding more than 7 days
• More than 80 cc blood loss (see Hygam chart )
• Endometrial thickness in ultrasound is normal which is equal to or less than 12 mm
• Gynecological examination is normal
• Pap smear results are normal
• Patient has Hb=11
Exclusion criteria:
• Hemoglobin high level of 16
• Bleeding is so severe that emergency measures needed
• Plan to become pregnant in the next three months
• Catching Systemic or Pelvic inflammatory disease
• Catching chronic diseases such as diabetes, lupus and thyroid problems
• Catching Organic diseases such as cancer of the Uterus or ovaries or other malignancies
• Conjugation of any herbal remedies or certain chemicals that interfere with the study drug or have an impact on menstrual bleeding Such as birth control pills containing estrogen and progesterone or just progestin
• Pregnancy and lactation
• Catching Known hyperprolactinemia
• Catching sub-mucosal or intramural fibroids which are larger than 5 cm
• The patient has no wish to consume these types of drugs
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bleeding volume. Timepoint: before and 3 month after intervention. Method of measurement: Higam chart(PBAC Questionaire).;Duration of bleeding. Timepoint: before and 3 month after intervention. Method of measurement: Questionaire.
- Secondary Outcome Measures
Name Time Method Hemoglobin concentration. Timepoint: Before the intervention, and at the end of each menstrual cycle. Method of measurement: Hemiglobincyanide method, Hemoglobin measuring kit.;Potential drug side effects. Timepoint: end of intervention. Method of measurement: Questionaire.;Quality of life. Timepoint: Before and the end of intervention. Method of measurement: Menorrhagia Questionaire.