Efficacy and Safety for Cimicifuga/Hypericum Product (CH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Phytopharm Consulting Brazil.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Herbarium Laboratório Botânico Ltda
Complexo Hospitalar Santa Casa de Misericordia de Porto alegre
Information provided by (Responsible Party):
Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier:
NCT01481025
First received: November 25, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Perimenopausal Disorder
Drug: Cimicifuga + Hiperico
Drug: Cimicifuga Herbarium
Drug: Aplause®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Phytopharm Consulting Brazil:

Primary Outcome Measures:
  • Menopause Rating Scale [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale*


Secondary Outcome Measures:
  • Hamilton's Depression Scale [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Questionair for Depression Symptoms

  • WHOQOL [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Starting Point (T-2) and Ending Point (T6)

  • Health Numbers [ Time Frame: 8 months (T-2 to T6) ] [ Designated as safety issue: No ]
    Starting Point (T0, T1, T3 and T6)


Estimated Enrollment: 210
Study Start Date: November 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481025

Contacts
Contact: Marli Chaves, Secretary +55 51 8130-8454 contato@phytopharm.com.br
Contact: Karla F Deud José, PharmD PhD +55 51 9279-3075 karla@phytopharm.com.br

Locations
Brazil
ISCMPA's Gynecology Ambulatory Not yet recruiting
Porto Alegre, RS, Brazil, 90020-090
Contact: Marli Chaves, Secretary    +55 51 81308454    contato@phytopharm.com.br   
Contact: Gustavo Remus, Physical Edu    +55 51 9191-6535    remus@phytopharm.com.br   
Principal Investigator: Carla Vanin, MD MSc PhD         
Sub-Investigator: Raquel P Dibi, MD MSc         
Sponsors and Collaborators
Phytopharm Consulting Brazil
Herbarium Laboratório Botânico 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 Misericórdia de Porto Alegre
  More Information

No publications provided

Responsible Party: Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier: NCT01481025     History of Changes
Other Study ID Numbers: Cimicifuga/Herbarium
Study First Received: November 25, 2011
Last Updated: November 28, 2011
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Phytopharm Consulting Brazil:
Climacteric
Depression
Herbal treatment

ClinicalTrials.gov processed this record on July 24, 2014