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

Sponsor

A. Vogel AG (Industry)

Overall Status

Terminated

CT.gov ID

NCT02032862

Collaborator

(none)

107

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Menopausal Hot Flushes	Drug: Sage extract, 3400 mg , DER 1:17	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Sweating

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sage tablets Sage extract, 3400 mg , DER 1:17, in once daily application over 12 weeks treatment phase	Drug: Sage extract, 3400 mg , DER 1:17
Placebo Comparator: Placebo Placebo, matching the verum in size and appearance, in once daily application over 12 weeks treatment phase

Arm

Intervention/Treatment

Experimental: Sage tablets

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

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

Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

Change from Baseline Hyperhidrosis Disease Severity Scale [Week 12]

Secondary Outcome Measures

Change from Baseline Menopause Rating Scale / MRS [Week 12]
Change from Baseline Modified Dem Tect [Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. M. Morger	Saint Gallen	St. Gall	Switzerland	9000

Sponsors and Collaborators

A. Vogel AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

A. Vogel AG

ClinicalTrials.gov Identifier:

NCT02032862

Other Study ID Numbers:

920157

First Posted:

Jan 10, 2014

Last Update Posted:

Jul 21, 2015

Last Verified:

Jul 1, 2015

Keywords provided by A. Vogel AG

menopause, hot flushes, hot flashes, salvia, sage, sweating

Additional relevant MeSH terms:

Flushing

Hot Flashes

Study Results

No Results Posted as of Jul 21, 2015