Anxiety, Efficacy, Tolerability
Conditions
Keywords
Passiflora, Crataegus and Salix, Mild and Moderate anxiety, Tablet, To evaluate the efficacy and tolerability of the combination
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.
Interventions
DRUGPassiflora, Crataegus e Salix
Comparison of different pharmaceutics forms of drug
Sponsors
Ativus Farmaceutica Ltda
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Scales | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation by adverse events relate. | 30 days |
Countries
Brazil
Contacts
Primary ContactDagoberto Brandão
Outcome results
None listed