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

A. Vogel AG

Status and phase: Terminated; Phase 4

Conditions: Menopausal Hot Flushes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02032862

920157

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 2 patient groups, including a placebo group

Sage tablets

Experimental group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

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