Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
- Registration Number
- NCT00944268
- Lead Sponsor
- Ativus Farmaceutica Ltda
- 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, prospective, open.
Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Liquid and solid Passiflora, Crataegus e Salix -
- Primary Outcome Measures
Name Time Method Hamilton Scales 30 days
- Secondary Outcome Measures
Name Time Method Safety evaluation by adverse events relate. 30 days
Trial Locations
- Locations (1)
Faculdade de Medicina do ABC
🇧🇷Santo André, São Paulo, Brazil