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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02032862
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : January 10, 2014
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : December 2013
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause Sweat
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline Hyperhidrosis Disease Severity Scale [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline Menopause Rating Scale / MRS [ Time Frame: Week 12 ]
  2. Change from Baseline Modified Dem Tect [ Time Frame: Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032862


Locations
Switzerland
Dr. M. Morger
Saint Gallen, St. Gall, Switzerland, 9000
Sponsors and Collaborators
Bioforce AG
More Information

Responsible Party: Bioforce AG
ClinicalTrials.gov Identifier: NCT02032862     History of Changes
Other Study ID Numbers: 920157
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Flushing
Hot Flashes
Signs and Symptoms