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

Menopausal Hot Flushes research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Menopausal Hot Flushes

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sage extract, 3400 mg , DER 1:17

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sage tabletsSage extract, 3400 mg , DER 1:17, in once daily application over 12 weeks treatment phase

PlaceboPlacebo, matching the verum in size and appearance, in once daily application over 12 weeks treatment phase

Study Status

Terminated

Start Date: December 2013

Completed Date: July 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change from Baseline Hyperhidrosis Disease Severity Scale

Secondary Outcome: Change from Baseline Menopause Rating Scale / MRS

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Bioforce AG

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02032862

Discuss Hyperhidrosis