Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety

• Status: Unknown status
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ativus Farmaceutica Ltda

Criteria

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