Efficacy and Safety for Cimicifuga/Hypericum Product

Perimenopausal Disorder Clinical Trial

— CH  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01481025
• Other study ID #: Cimicifuga/Herbarium
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 25, 2011
• Last updated: November 28, 2011
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2011
• Source: Phytopharm Consulting Brazil
• Contact: Marli Chaves, Secretary
• Phone: +55 51 8130-8454
• Email: contato[@]phytopharm.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Perimenopausal Disorder

Intervention

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
• Cimicifuga Herbarium
2 caps, 80mg/caps, once a day for 1-3 months 1 caps, 80mg/caps, once a day for 3-6 months
• Aplause®
4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months

Locations

Country	Name	City	State
Brazil	ISCMPA's Gynecology Ambulatory	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Phytopharm Consulting Brazil	Complexo Hospitalar Santa Casa de Misericordia de Porto alegre, Herbarium Laboratório Botânico Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopause Rating Scale	Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale*	8 months	No
Secondary	Hamilton's Depression Scale	Questionair for Depression Symptoms	8 months	No
Secondary	WHOQOL	Starting Point (T-2) and Ending Point (T6)	8 months	No
Secondary	Health Numbers	Starting Point (T0, T1, T3 and T6)	8 months (T-2 to T6)	No