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

Last updated: July 7, 2014
Sponsor: Marjan Industria e Comercio ltda
Overall Status: Completed

Phase

3

Condition

Anxiety Disorders

Panic Disorders

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT00794456
MJ 3002-08
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • generalized anxiety disorder

  • HAM-A scale < 17 and > 30

Exclusion

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 antidepressantaction

  • psychotherapy

  • drug or alcohol dependence

  • gastrointestinal ulcer history

  • hyperthyroidism

  • neoplasia

  • coagulation disorders

Study Design

Total Participants: 150
Study Start date:
September 01, 2009
Estimated Completion Date:
October 31, 2013

Study 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.

Connect with a study center

  • Unidade de Farmacologia Clínica - UNIFAC

    Fortaleza, Ceará 60430-270
    Brazil

    Site Not Available

  • SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo

    Sao Paulo, 04024-002
    Brazil

    Site Not Available

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