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

Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794456
• Other study ID #: MJ 3002-08
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2008
• Last updated: July 7, 2014
• Start date: September 2009
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: Marjan Industria e Comercio ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

Intervention

Drug:
• Passiflora ; Crataegus and Salix
1 tablet PO twice a day
• Valeriana
1 tablet PO twice a day

Locations

Country	Name	City	State
Brazil	Unidade de Farmacologia Clínica - UNIFAC	Fortaleza	Ceará
Brazil	SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Marjan Industria e Comercio ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton anxiety scale		6 weeks	No
Secondary	Insomnia gravity index; global clinical impression; patients global evaluation		6 weeks	No