Efficacy and Safety for Cimicifuga/Hypericum Product
Launched by PHYTOPHARM CONSULTING BRAZIL · Nov 28, 2011
Trial Information
Current as of April 29, 2025
Unknown status
Keywords
ClinConnect Summary
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.
Gender
FEMALE
Eligibility 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
About Phytopharm Consulting Brazil
Phytopharm Consulting Brazil is a leading clinical trial sponsor specializing in the development and evaluation of phytotherapeutic products. With a strong focus on the integration of scientific research and traditional herbal medicine, the organization is dedicated to advancing the understanding of plant-based therapies through rigorous clinical studies. Leveraging a team of experienced professionals and a robust network of healthcare partners, Phytopharm Consulting Brazil is committed to ensuring regulatory compliance and high-quality data collection, ultimately contributing to the safe and effective use of phytopharmaceuticals in diverse therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Porto Alegre, Rs, Brazil
Patients applied
Trial Officials
Karla F Deud José, Pharm PhD
Study Chair
Phytopharm Consulting Brazil - karla@phytopharm.com.br
Carla Vanin, MD MSc PhD
Principal Investigator
Federal University of Health Science of Porto Alegre
Raquel P Dibi, MD MSc
Principal Investigator
Irmandade Santa Casa de Misericórdia de Porto Alegre
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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