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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Ativus Farmaceutica Ltda.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ativus Farmaceutica Ltda
ClinicalTrials.gov Identifier:
NCT00944268
First received: July 22, 2009
Last updated: July 23, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Anxiety
Efficacy
Tolerability
 Drug: Passiflora, Crataegus e Salix
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
Drug Information available for: Passiflora
U.S. FDA Resources

Further study details as provided by Ativus Farmaceutica Ltda:

Primary Outcome Measures:
  • Hamilton Scales [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety evaluation by adverse events relate. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 124
Study Start Date: September 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liquid and solid Drug: Passiflora, Crataegus e Salix
Comparison of different pharmaceutics forms of drug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944268

Contacts
Contact: Dagoberto Brandão 55 11 36733763 dagoberto@phcbrasil.com.br

Locations
Brazil
Faculdade de Medicina do ABC Not yet recruiting
Santo André, São Paulo, Brazil, 09060650
Contact: Elie Fiss     55 1149935469     eliefiss@uol.com.br    
Principal Investigator: Elie Fiss            
Sponsors and Collaborators
Ativus Farmaceutica Ltda
Investigators
Principal Investigator: Elie Fiss Faculdade de Medicina do ABC
  More Information

No publications provided

Responsible Party: Olinto Mascarenhas Marques, ATIVUS FARMACÊUTICA LTDA
ClinicalTrials.gov Identifier: NCT00944268     History of Changes
Other Study ID Numbers: E01-AT-CAL-03-08
Study First Received: July 22, 2009
Last Updated: July 23, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Ativus Farmaceutica Ltda:
Passiflora, Crataegus and Salix
Mild and Moderate anxiety
Tablet
To evaluate the efficacy and tolerability of the combination

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013