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

Ativus Farmaceutica

Status and phase

Unknown

Phase 3

Conditions

Efficacy

Tolerability

Anxiety

Treatments

Drug: Passiflora, Crataegus e Salix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00944268

E01-AT-CAL-03-08

Details and patient eligibility

About

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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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