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Completed

NCT Number: NCT00794456

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

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.

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Key information

Conditions

Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unidade de Farmacologia Clínica - UNIFAC, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passiflora ; Crataegus and Salix

Drug

1 tablet PO twice a day

Other names: Pasalix

Valeriana

Drug

1 tablet PO twice a day

Other names: Valeriana officinalis 50 mg

Primary outcomes

  1. Hamilton anxiety scale

    Time frame: 6 weeks

Secondary outcomes

  1. Insomnia gravity index; global clinical impression; patients global evaluation

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Marjan Industria e Comercio ltda

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 20, 2008
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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