Effect of a Menohelp Barij® capsule on early symptoms of menopause
- Conditions
- The early menopausal symptoms.Menopausal and other perimenopausal disorders
- Registration Number
- IRCT20100414003706N35
- Lead Sponsor
- Barij Essence Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 100
Aged 50-59 years
12-72 months after last menstrual period
Natural menopause
Having at least 3 hot flashes daily during one week follow-up
Living with husband
BMI 18 to 30 kg/m2
Having a least 6 years Education
Contraindications for hormone therapy, including history of breast cancer, endometrial hyperplasia, or any estrogen-related cancers in the woman or her first-degree family
Use of hormone therapy during past 3 months
Allergy to estrogen or medicinal herbs
Any history of cervical cancer, liver diseases, kidney diseases, gastrointestinal diseases, coagulation diseases, depression or hyperthyroidism.
Surgery during the past 3 months
Chronic diseases requiring treatment including severe hypertension (160/110) and known diabetes, or malabsorption syndrome
Myocardial or cerebral infarction over the past 3 months or History of complicated myocardial or cerebral infarction
History of venous thrombosis
history of known fibromyoma
Heavy smoker (more than 15 cigarettes/day)
Regular consumption of alcoholic beverages and alcohol dependence
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall score and sub-scales (vasomotor, physical, psychological, and sexual symptoms) of early menopausal symptoms. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Green climacteric scale.;Number of daily hot flashes. Timepoint: before intervention and 4 and 12 weeks after intervention. Method of measurement: daily registration form.;Severity of hot flashes. Timepoint: before intervention and 4 and 12 weeks after intervention. Method of measurement: daily registration form.
- Secondary Outcome Measures
Name Time Method Total and subscales scores of quality of life. Timepoint: before intervention and 12 weeks after intervention. Method of measurement: The Menopause-Specific Quality of Life (MENQOL).;Total improvement status for early symptoms of menopause. Timepoint: 4 and 12 weeks after intervention. Method of measurement: one question with three Likert options.;Quality of sleep score. Timepoint: 4 weeks after intervention. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI).