Trial | NCT00794456  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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 Started
Sep 30
2009
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Jul 08
2014
Estimate

Drug Passiflora ; Crataegus and Salix

1 tablet PO twice a day

  • Other names: Pasalix

Drug Valeriana

1 tablet PO twice a day

  • Other names: Valeriana officinalis 50 mg

1 Experimental

Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.

2 Active Comparator

Valeriana officinalis 50 mg

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
No Results Posted