Therapeutic Effect of an Herbal Medicine on Anxiety

Last updated: August 9, 2010
Sponsor: Millet Roux
Overall Status: Trial Status Unknown

Phase

3

Condition

Anxiety Disorders

Mood Disorders

Panic Disorders

Treatment

N/A

Clinical Study ID

NCT01178632
MR4009
  • Ages 18-65
  • All Genders

Study Summary

Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of generalized anxiety disorder

  • HAM-A scale > 17 and <30

Exclusion

Exclusion Criteria:

  • HAM-A scale > 30

  • Psychotherapy

Study Design

Total Participants: 136
Study Start date:
October 01, 2010
Estimated Completion Date:
July 31, 2012

Study Description

The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.

The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).

Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?

Connect with a study center

  • Clinical Pharmacology Unit - Unifac

    Fortaleza, Ceara 60430-270
    Brazil

    Site Not Available

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