The early menopausal symptoms. Menopausal and other perimenopausal disorders
Conditions
Interventions
Intervention 1: Intervention group: Recieving Menohelp Barij® 550 mg Herbal Capsule , containing Extracts of Actaea racemosa L., Glycine max , Dioscorea villosa, Arctium lappa and Vitex agnus- castus
standardized based on at least 40 mg total phenolic according to daidzein and 3 mg diosgenin in each capsule, produced by Barij Essence Pharmaceutical company, Kashan-Iran
once daily for 90 days. Intervention 2: Control group: placebo capsules identical to Menohelp Barij® herbal capsules
produced by Barij Essence Pharmaceutical company, Kashan-Iran
once daily for 90 days.
Sponsors
Barij Essence Pharmaceutical Company
Eligibility
Sex/Gender
Female
Age
50 Years to 59 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Bekhradi
Barij Medicinal Plants Research Center
Outcome results
None listed