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Efficacy and Safety for Cimicifuga/Hypericum Product

NCT01481025 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2011-11-29

No results posted yet for this study

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.

Conditions

  • Perimenopausal Disorder

Interventions

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

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

DRUG

Aplause®

4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months

Sponsors & Collaborators

  • Herbarium Laboratorio Botanico Ltda

    collaborator INDUSTRY

  • Complexo Hospitalar Santa Casa de Misericordia de Porto alegre

    collaborator UNKNOWN

  • Phytopharm Consulting Brazil

    lead NETWORK

Principal Investigators

  • Karla F Deud José, Pharm PhD · Phytopharm Consulting Brazil - [email protected]

  • Carla Vanin, MD MSc PhD · Federal University of Health Science of Porto Alegre

  • Raquel P Dibi, MD MSc · Irmandade Santa Casa de Misericórdia de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481025 on ClinicalTrials.gov