Comparing the effect of Fennel extract and placebo on menopausal symptoms
Phase 2
- Conditions
- menopausal symptoms.Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
- Registration Number
- IRCT2016120528967N4
- Lead Sponsor
- Vice chancellor for research, Kermanshah University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
the women ranging from 45 to 65 years old; menstrual period is elapsed minimally one year and maximally three years; the number of their hot flushes is at least 2 times a day. Exclusion criteria: smoking; undergoing hormone; antibiotics therapy for a period of 3 months at least; systemic diseases such as kidney disease; blood pressure; diabetes; blood fat; depression and anxiety (anxiety and depression diagnosis based on diagnostic criteria DSM5 by psychiatrist); taking anti-thyroid drugs; gabapentin; SSRI; sulfonamides; methotrexate; Tryamtryn; sulfasalazine; estrogen; uptake of traditional medicines such as drug-induced flushing.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vasomotor. Timepoint: before intervention-2 weeks later- 4 weeks later- 8 weeks later. Method of measurement: Green questionnaire.;Depression. Timepoint: before intervention-2 weeks later- 4 weeks later- 8 weeks later. Method of measurement: Green questionnaire.;Sexual Function. Timepoint: before intervention-2 weeks later- 4 weeks later- 8 weeks later. Method of measurement: Green questionnaire.;Anxiety. Timepoint: before intervention-2 weeks later- 4 weeks later- 8 weeks later. Method of measurement: Green questionnaire.
- Secondary Outcome Measures
Name Time Method