Clinical Trial: Efficacy and Safety of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Multicentric, Randomized, Double Blind Study for Assessment of Efficacy and Tolerability of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sw
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 Summary:
Sponsor: Bioforce AG
Current Primary Outcome: Change from Baseline Hyperhidrosis Disease Severity Scale [ Time Frame: Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from Baseline Menopause Rating Scale / MRS [ Time Frame: Week 12 ]
- Change from Baseline Modified Dem Tect [ Time Frame: Week 12 ]
Original Secondary Outcome: Same as current
Information By: Bioforce AG
Dates:
Date Received: January 8, 2014
Date Started: December 2013
Date Completion:
Last Updated: July 20, 2015
Last Verified: July 2015
