Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety

Anxiety Clinical Trial

— E01ATCAL0308  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00944268
• Other study ID #: E01-AT-CAL-03-08
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 22, 2009
• Last updated: July 23, 2009
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: July 2009
• Source: Ativus Farmaceutica Ltda
• Contact: Dagoberto Brandão
• Phone: 55 11 36733763
• Email: dagoberto[@]phcbrasil.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Efficacy
• Tolerability

Intervention

Drug:
• Passiflora, Crataegus e Salix
Comparison of different pharmaceutics forms of drug

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Ativus Farmaceutica Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Scales		30 days	Yes
Secondary	Safety evaluation by adverse events relate.		30 days	Yes