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

Phase 3

Completed

• Conditions: Anxiety Disorder
• Interventions: Drug: Passiflora ; Crataegus and Salix; Drug: Valeriana

• Registration Number: NCT00794456
• Lead Sponsor: Marjan Industria e Comercio ltda

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.

Study Timeline

• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-20
• Study Start: 2009-09
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Passiflora ; Crataegus and Salix	Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
2	Valeriana	Valeriana officinalis 50 mg

Primary Outcome Measures

Name	Time	Method
Hamilton anxiety scale	6 weeks

Secondary Outcome Measures

Name	Time	Method
Insomnia gravity index; global clinical impression; patients global evaluation	6 weeks

Trial Locations

Locations (2)

Unidade de Farmacologia Clínica - UNIFAC; 🇧🇷 Fortaleza, Ceará, Brazil

SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo; 🇧🇷 Sao Paulo, Brazil