Efficacy and Safety for Cimicifuga/Hypericum Product

Phase 3

• Conditions: Perimenopausal Disorder
• Interventions: Drug: Cimicifuga + Hiperico; Drug: Cimicifuga Herbarium; Drug: Aplause®

• Registration Number: NCT01481025
• Lead Sponsor: Phytopharm Consulting Brazil

Brief 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.

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Study First Posted: 2011-11-29
• Last Update Posted: 2011-11-29
• Primary Completion: 2012-06
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• Climacteric women 45-60 years old - pre and postmenopausal
• Climacteric complains for at least 3 months
• No treatments for at least 2 months
• MRS score 0.4 or more for at least 3 items
• Hamilton's Scale score from 15-23

Exclusion Criteria

• Hormon Therapy or any other for the last 3 months
• Antidepressive and Hypnotic medication for the last 3 months
• Sever illness (cardiac, hepatic, renal, digestive or metabolic) or TSH alteration
• History for allergies and hipersensitivity to any component of the drugs formulations
• No knowledge for reading or writing
• Suicide risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cimicifuga+Hiperico	Cimicifuga + Hiperico	80 + 450 mg / tablet
Cimicifuga Herbarium	Cimicifuga Herbarium	80 mg / caps
Aplause®	Aplause®	20 mg / tablet

Primary Outcome Measures

Name	Time	Method
Menopause Rating Scale	8 months	Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale\*

Secondary Outcome Measures

Name	Time	Method
Hamilton's Depression Scale	8 months	Questionair for Depression Symptoms
WHOQOL	8 months	Starting Point (T-2) and Ending Point (T6)
Health Numbers	8 months (T-2 to T6)	Starting Point (T0, T1, T3 and T6)

Trial Locations

Locations (1)

ISCMPA's Gynecology Ambulatory; 🇧🇷 Porto Alegre, RS, Brazil