Therapeutic Effect of an Herbal Medicine on Anxiety
A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder
1 other identifier
interventional
136
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 10, 2010
August 1, 2010
1.2 years
August 8, 2010
August 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton anxiety scale score
The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
Four weeks
Secondary Outcomes (2)
Insomnia gravity index
Four weeks
Clinical global impression rate scale and Patient global evaluation rate scale
Four weeks
Study Arms (2)
Passiflora, Anxiety Disorders
EXPERIMENTAL1 tablet Passiflora;Crataegus;Salix; PO;BID
Valeriane, Anxiety Disorder
ACTIVE COMPARATOR1 tablet Valeriana officinalis, PO, BID
Interventions
01 tablet Passiflora p.o., b.i.d.
Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of generalized anxiety disorder
- HAM-A scale \> 17 and \<30
You may not qualify if:
- HAM-A scale \> 30
- Psychotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Millet Rouxlead
Study Sites (1)
Clinical Pharmacology Unit - Unifac
Fortaleza, Ceará, 60430-270, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MARIA ELISABETE A MORAES, MD, PhD
CLINICAL PHARMACOLOGY UNIT - UNIFAC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2010
First Posted
August 10, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2011
Study Completion
July 1, 2012
Last Updated
August 10, 2010
Record last verified: 2010-08