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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Bioforce AG
Sponsor:
Information provided by (Responsible Party):
Bioforce AG
ClinicalTrials.gov Identifier:
NCT02032862
First received: January 8, 2014
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Menopausal Hot Flushes
Drug: Sage extract, 3400 mg , DER 1:17
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bioforce AG:

Primary Outcome Measures:
  • Change from Baseline Hyperhidrosis Disease Severity Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline Menopause Rating Scale / MRS [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline Modified Dem Tect [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02032862

Contacts
Contact: Silvia Bommer, Dr. med. 0041 7145 ext 46204 s.bommer@bioforce.ch

Locations
Switzerland
Dr. M. Morger Recruiting
Saint Gallen, St. Gall, Switzerland, 9000
Principal Investigator: Martin Morger, Dr. med.         
Sponsors and Collaborators
Bioforce AG
  More Information

No publications provided

Responsible Party: Bioforce AG
ClinicalTrials.gov Identifier: NCT02032862     History of Changes
Other Study ID Numbers: 920157
Study First Received: January 8, 2014
Last Updated: January 9, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Bioforce AG:
menopause, hot flushes, hot flashes, salvia, sage, sweating

Additional relevant MeSH terms:
Flushing
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014