Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
Status:
Unknown status
Sponsors
Ativus Farmaceutica Ltda
Abstract:
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.
Last Verified:June/30/2009
First Submitted:July/21/2009
Estimated Enrollment Submitted:July/21/2009
First Posted:July/22/2009
Last Update Submitted:July/22/2009
Last Update Posted:July/23/2009
Actual Study Start Date:August/31/2009
Estimated Primary Completion Date:November/30/2009
Estimated Study Completion Date:December/31/2009
Condition or disease:Anxiety
Efficacy
Tolerability
Intervention/treatment:
Drug: Liquid and solid
Phase:Phase 3
Study design:
Study Type:Interventional
Allocation:Randomized
Primary Purpose:Treatment
Masking:None (Open Label)
Arm group:
ArmIntervention/treatment
Experimental: Liquid and solid
Drug: Liquid and solid
Comparison of different pharmaceutics forms of drug
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
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

Outcome:
Primary Outcome Measures
1. Hamilton Scales [30 days]
Secondary Outcome Measures
1. Safety evaluation by adverse events relate. [30 days]
Open in
Clinical Trial
Relations:
Diseases
(1)
Drugs
(1)
Genes
(1)
Organisms
(3)
Affiliates
(2)
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