This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Ativus Farmaceutica Ltda.
Recruitment status was:  Not yet recruiting
Information provided by:
Ativus Farmaceutica Ltda Identifier:
First received: July 22, 2009
Last updated: July 23, 2009
Last verified: July 2009

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
Intervention Model: Factorial Assignment
Masking: None (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:

Further study details as provided by Ativus Farmaceutica Ltda:

Primary Outcome Measures:
  • Hamilton Scales [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Safety evaluation by adverse events relate. [ Time Frame: 30 days ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00944268

Contact: Dagoberto Brandão 55 11 36733763

Faculdade de Medicina do ABC Not yet recruiting
Santo André, São Paulo, Brazil, 09060650
Contact: Elie Fiss    55 1149935469   
Principal Investigator: Elie Fiss         
Sponsors and Collaborators
Ativus Farmaceutica Ltda
Principal Investigator: Elie Fiss Faculdade de Medicina do ABC
  More Information

Responsible Party: Olinto Mascarenhas Marques, ATIVUS FARMACÊUTICA LTDA 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

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders processed this record on September 20, 2017