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

NCT ID: NCT02032862

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

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

Conditions

Menopausal Hot Flushes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sage tablets

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

Group Type: EXPERIMENTAL

Sage extract, 3400 mg , DER 1:17

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Sage extract, 3400 mg , DER 1:17

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

A. Vogel AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. M. Morger

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Switzerland

Other Identifiers

920157

Identifier Type: -

Identifier Source: org_study_id