Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause. Menopausal and female climacteric
Conditions
Interventions
Intervention 1: Daily oral consumption one 45 mg red clover capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week. Intervention 2: In
Treatment - Drugs
Placebo
Daily oral consumption one 45 mg red clover capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week.
In the control group: Daily oral consumption one 45 mg starch powder capsule each morning with the breakfast meal for 8 weeks continued from end of the second week to end of the tenth week.
Sponsors
Isfahan University of Medical Sciences.
Eligibility
Sex/Gender
Female
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: Main Inclusion criteria: Age>45 years, Amenorrhea>12 month and<5 year duration, Kupperman Index Score?15, Good general health. Able to give informed consent (Able to read and write). Main non-inclusion criteria and exclusion: Having hormone therapy contraindications, Use of drugs that influence vasomotors symptoms, Occurrence of any serious event in the 6 months prior the study, taking the drugs that might reduce absorption of isoflavones, Consuming less than %80 of the expected capsules during one month.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menopausal symptoms. Timepoint: Before the intervention (treatment), 4 and 8 weeks after beginning the intervention. Method of measurement: Kupperman menopausal index.;Quality of life. Timepoint: Before the intervention (treatment) and 8 weeks after beginning the intervention. Method of measurement: Menopause -specific quality of life questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKobra Salehi
Isfahan University of Medical Sciences.
Outcome results
None listed