Back to resultsEfficacy and Tolerability Study to Treat Mild and Moderate Anxiety (E01ATCAL0308)
Primary Purpose
Anxiety, Efficacy, Tolerability
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Passiflora, Crataegus e Salix
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Passiflora, Crataegus and Salix, Mild and Moderate anxiety, Tablet, To evaluate the efficacy and tolerability of the combination
Eligibility 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
Sites / Locations
- Faculdade de Medicina do ABC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liquid and solid
Arm Description
Outcomes
Primary Outcome Measures
Hamilton Scales
Secondary Outcome Measures
Safety evaluation by adverse events relate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00944268
Brief Title
Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ativus Farmaceutica Ltda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Efficacy, Tolerability
Keywords
Passiflora, Crataegus and Salix, Mild and Moderate anxiety, Tablet, To evaluate the efficacy and tolerability of the combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liquid and solid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Passiflora, Crataegus e Salix
Intervention Description
Comparison of different pharmaceutics forms of drug
Primary Outcome Measure Information:
Title
Hamilton Scales
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Safety evaluation by adverse events relate.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dagoberto Brandão
Phone
55 11 36733763
Email
dagoberto@phcbrasil.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie Fiss
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060650
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elie Fiss
Phone
55 1149935469
Email
eliefiss@uol.com.br
First Name & Middle Initial & Last Name & Degree
Elie Fiss
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
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