Therapeutic Effect of an Herbal Medicine on Anxiety

Anxiety Disorders Clinical Trial

Official title:

A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01178632
• Other study ID #: MR4009
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 8, 2010
• Last updated: August 9, 2010
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2010
• Source: Millet Roux
• Contact: MARIA ELISABETE A MORAES, MD, PhD
• Phone: 5585-32232903
• Email: betemora[@]matrix.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of generalized anxiety disorder

• HAM-A scale > 17 and <30

Exclusion Criteria:

• HAM-A scale > 30

• Psychotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Drug:
• Passiflora
01 tablet Passiflora p.o., b.i.d.
• Valeriana officinalis
Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.

Locations

Country	Name	City	State
Brazil	Clinical Pharmacology Unit - Unifac	Fortaleza	Ceara

Sponsors (1)

Lead Sponsor	Collaborator
Millet Roux

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Insomnia gravity index	The secondary outcome measure for effectiveness will be the score of the Insomnia gravity index. This questionnaire 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	Yes
Secondary	Clinical global impression rate scale and Patient global evaluation rate scale	The other secondary outcome measure for effectiveness will be the clinical global impression rate scale and patient global evaluation rate scale. These scales 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	Yes

External Links

•   ANXIETY DISORDERS
•   Passion Flower
•   Valeriana officinalis