Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety Efficacy Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liquid and solid

Group Type EXPERIMENTAL

Passiflora, Crataegus e Salix

Intervention Type DRUG

Comparison of different pharmaceutics forms of drug

Interventions

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Passiflora, Crataegus e Salix

Comparison of different pharmaceutics forms of drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No