NCT01481025

Efficacy and Safety for Cimicifuga/Hypericum Product

Phase 3 Study - Efficacy and Tolerance for the Mixture of Dry Extracts Black Cohosh and Saint John's Worth Versus Isolated Black Cohosh Extract for the Climacteric Symptoms' Control

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Phytopharm Consulting Brazil · Network
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.

Detailed description

2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life. The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator. This protocol was performed for the best of our volunteers.

Conditions

• Perimenopausal Disorder

Interventions

Type	Name	Description
DRUG	Cimicifuga + Hiperico	1 tablet, 80+450mg/tablet, twice a day for 1-3 months 1 tablet, 80+450mg/tablet, once a day for 3-6 months
DRUG	Cimicifuga Herbarium	2 caps, 80mg/caps, once a day for 1-3 months 1 caps, 80mg/caps, once a day for 3-6 months
DRUG	Aplause®	4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2011-11-29
• Last updated: 2011-11-29

Locations

1 site across 1 country: Brazil