Status:
UNKNOWN
Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
Lead Sponsor:
Ativus Farmaceutica Ltda
Conditions:
Anxiety
Efficacy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety. Clinical study phase III, multicenter, ...
Eligibility Criteria
Inclusion
- Patients who achieve scores between 18 and 29 points in the Hamilton Scale for Anxiety;
- Individuals of any ethnic group male and female, aged above 18 years;
- Consent of the subject of research (a consent form signed).
Exclusion
- Patients with known hypersensitivity to any components of the formula;
- Pregnant women and nursing mothers;
- Patients with endogenous depression, schizophrenia, suicidal tendency;
- Patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator;
- Addiction to drugs, including alcohol, at the discretion of the investigator;
- Patients who are using any medication that could interfere with the effect of the drug under study;
- Impossibility of compliance to the protocol
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00944268
Start Date
September 1 2009
End Date
January 1 2010
Last Update
July 24 2009
Active Locations (1)
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1
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil, 09060650