Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety

Study Overview
=================
Brief Summary
-----------------
Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be followed by a post treatment visit. Hamilton anxiety scale will be used to assess anxiety.

Detailed Description
-----------------
Passiflora incarnata L; Crataegus Oxyacantha L are plant-derived treatment widely used to treat anxiety disorders. This study will compare the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L for the treatment of mild and moderate anxiety. 150 participants will be randomly assigned to receive the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. or Valeriana officinalis for 6 weeks. A post treatment visit will be done 2 weeks for safety evaluation. Primary outcome: Hamilton anxiety (HAM-A) scale Secondary outcome: Insomnia quality index, Global clinical impression and patients global evaluation scales. Side effects will be monitorized throughout the study.

Official Title
-----------------
Double Blind, Randomized Study, Controlled by Valeriana Officinalis, of Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Patients With Mild and Moderate Anxiety

Conditions
-----------------
Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Passiflora ; Crataegus and Salix
* Drug: Valeriana


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: generalized anxiety disorder HAM-A scale < 17 and > 30 Exclusion Criteria: hypersensibility to any component patients with depression, schizophrenia ou suicidal ideas pregnant ou lactating heart, liver, lung or kidney important condition use of digitalis, AAS, anticoagulants agents, drugs with sedative or antidepressant action psychotherapy drug or alcohol dependence gastrointestinal ulcer history hyperthyroidism neoplasia coagulation disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. | Drug: Passiflora ; Crataegus and Salix<br>* 1 tablet PO twice a day<br>* Other names: Pasalix;|
| Active Comparator: 2<br>Valeriana officinalis 50 mg | Drug: Valeriana<br>* 1 tablet PO twice a day<br>* Other names: Valeriana officinalis 50 mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton anxiety scale |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia gravity index; global clinical impression; patients global evaluation |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Passiflora, Crataegus, Herbal, Valeriana, anxiety