Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Status:
Completed
Sponsors
Marjan Industria e Comercio ltda
Abstract:
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.
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.
Last Verified:June/30/2014
First Submitted:November/18/2008
Estimated Enrollment Submitted:November/18/2008
First Posted:November/19/2008
Last Update Submitted:July/6/2014
Last Update Posted:July/7/2014
Actual Study Start Date:August/31/2009
Estimated Primary Completion Date:September/30/2013
Estimated Study Completion Date:September/30/2013
Condition or disease:Anxiety Disorder
Intervention/treatment:
Drug: 1
Drug: 2
Phase:Phase 3
Study design:
Study Type:Interventional
Allocation:Randomized
Primary Purpose:Treatment
Masking:Double (Participant, Investigator)
Arm group:
ArmIntervention/treatment
Experimental: 1
Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
Drug: 1
1 tablet PO twice a day
Active Comparator: 2
Valeriana officinalis 50 mg
Drug: 2
1 tablet PO twice a day
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
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

Outcome:
Primary Outcome Measures
1. Hamilton anxiety scale [6 weeks]
Secondary Outcome Measures
1. Insomnia gravity index; global clinical impression; patients global evaluation [6 weeks]
Open in
Clinical Trial
Relations:
Diseases
(2)
Drugs
(3)
Genes
(1)
Organisms
(4)
Affiliates
(3)
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