Efficacy and Safety of Sage Tablets Compared to Placebo in Menopausal Patients With Hot Flushes and Sweating

Phase 4TerminatedNCT02032862

A. Vogel AG107 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

107

Conditions

Menopausal Hot Flushes

Interventions

Sage extract, 3400 mg , DER 1:17DRUG

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. M. Morger

Sankt Gallen, Canton of St. Gallen, Switzerland

Outcomes

Primary Outcomes

Change from Baseline Hyperhidrosis Disease Severity Scale

Time frame: Week 12

Secondary Outcomes

Change from Baseline Menopause Rating Scale / MRS

Time frame: Week 12

Change from Baseline Modified Dem Tect

Time frame: Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.