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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders
• Intervention / Treatment: Drug: Passiflora; Drug: Valeriana officinalis

Detailed 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?

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: MARIA ELISABETE A MORAES, MD, PhD; Phone Number: 5585-32232903; Email: betemora@matrix.com.br

Study Locations

• Brazil
  • Ceara
    • Fortaleza, Ceara, Brazil, 60430-270
      • Clinical Pharmacology Unit - Unifac
      • Principal Investigator: MARIA ELISABETE A MORAES, MD, PhD
      • Sub-Investigator: ALEXANDRE AQUINO CAMARA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of generalized anxiety disorder
• HAM-A scale > 17 and <30

Exclusion Criteria:

• HAM-A scale > 30
• Psychotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passiflora, Anxiety Disorders; 1 tablet Passiflora;Crataegus;Salix; PO;BID	Drug: Passiflora; 01 tablet Passiflora p.o., b.i.d.; Other Names: PASSIFLORINE
Active Comparator: Valeriane, Anxiety Disorder; 1 tablet Valeriana officinalis, PO, BID	Drug: Valeriana officinalis; Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.; Other Names: VALERIANE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Millet Roux
• Investigators: Study Director: MARIA ELISABETE A MORAES, MD, PhD, Clinical Pharmacology Unit - Unifac

Publications and helpful links

Helpful Links

• ANXIETY DISORDERS
• Passion Flower
• Valeriana officinalis

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: August 8, 2010
• First Submitted That Met QC Criteria: August 9, 2010
• First Posted (Estimate): August 10, 2010

Study Record Updates

• Last Update Posted (Estimate): August 10, 2010
• Last Update Submitted That Met QC Criteria: August 9, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Anxiety; Herbal; Phytotherapy; Passiflora; Valeriana
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MR4009