Efficacy and Safety of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating
Phase 4
Terminated
- Conditions
- Menopausal Hot Flushes
- Registration Number
- NCT02032862
- Lead Sponsor
- A. Vogel AG
- Brief Summary
Sage tablets ( 3400 mg extract from fresh sage leaves, DER 1:17) in a once daily application over 12 treatment weeks are compared against placebo in 200 menopausal patients with ≥ 5 hot flushes daily and a Hyperhidrosis Scale score ≥ 2
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 107
Inclusion Criteria
- Menopausal since ≥ 1 year
- ≥ 5 hot flushes /24 hours
- Hyperhidrosis Scale score ≥ 2
Exclusion Criteria
- Affections like asthma, COPD, depression, diabetes, epilepsy, hyper- and hypothyreosis, malign tumours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline Hyperhidrosis Disease Severity Scale Week 12
- Secondary Outcome Measures
Name Time Method Change from Baseline Modified Dem Tect Week 12 Change from Baseline Menopause Rating Scale / MRS Week 12
Trial Locations
- Locations (1)
Dr. M. Morger
🇨🇭Saint Gallen, St. Gall, Switzerland