Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety (E01ATCAL0308)

Clinical Study Phase III, Multicenter, Prospective, Open 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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety; Efficacy; Tolerability
• Intervention / Treatment: Drug: Passiflora, Crataegus e Salix

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Santo André, São Paulo, Brazil, 09060650
      • Faculdade de Medicina do ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid and solid	Drug: Passiflora, Crataegus e Salix; Comparison of different pharmaceutics forms of drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hamilton Scales	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety evaluation by adverse events relate.	30 days

Collaborators and Investigators

• Sponsor: Ativus Farmaceutica Ltda
• Investigators: Principal Investigator: Elie Fiss, Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): January 1, 2010

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 24, 2009
• Last Update Submitted That Met QC Criteria: July 23, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Tablet; Passiflora, Crataegus and Salix; Mild and Moderate anxiety; To evaluate the efficacy and tolerability of the combination
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: E01-AT-CAL-03-08