Efficacy and Safety for Cimicifuga/Hypericum Product (CH)

November 28, 2011 updated by: Phytopharm Consulting Brazil

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • ISCMPA's Gynecology Ambulatory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cimicifuga+Hiperico
80 + 450 mg / tablet
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
Active Comparator: Cimicifuga Herbarium
80 mg / caps
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
Active Comparator: Aplause®
20 mg / tablet
Drug: Aplause®
4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menopause Rating Scale
Time Frame: 8 months
Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale*
8 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phytopharm Consulting Brazil

Collaborators

Herbarium Laboratorio Botanico Ltda
Complexo Hospitalar Santa Casa de Misericordia de Porto alegre

Investigators

  • Study Chair: Karla F Deud José, Pharm PhD, Phytopharm Consulting Brazil - karla@phytopharm.com.br
  • Principal Investigator: Carla Vanin, MD MSc PhD, Federal University of Health Science of Porto Alegre
  • Principal Investigator: Raquel P Dibi, MD MSc, Irmandade Santa Casa de Misericordia de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

November 25, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cimicifuga/Herbarium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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