- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481025
Efficacy and Safety for Cimicifuga/Hypericum Product (CH)
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
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Marli Chaves, Secretary
- Phone Number: +55 51 8130-8454
- Email: contato@phytopharm.com.br
Study Contact Backup
- Name: Karla F Deud José, PharmD PhD
- Phone Number: +55 51 9279-3075
- Email: karla@phytopharm.com.br
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90020-090
- ISCMPA's Gynecology Ambulatory
-
Contact:
- Marli Chaves, Secretary
- Phone Number: +55 51 81308454
- Email: contato@phytopharm.com.br
-
Contact:
- Gustavo Remus, Physical Edu
- Phone Number: +55 51 9191-6535
- Email: remus@phytopharm.com.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
|
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
Sponsor
Collaborators
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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