Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety

Phase 3

• Conditions: Anxiety; Efficacy; Tolerability
• Interventions: Drug: Passiflora, Crataegus e Salix

• 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

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Last Update Submitted: 2009-07-23
• Last Update Posted: 2009-07-24
• Study Start: 2009-09
• Primary Completion: 2009-12
• Study Completion: 2010-01

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