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Therapeutic Effect of an Herbal Medicine on Anxiety

Primary Purpose

Anxiety Disorders

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Passiflora
Valeriana officinalis
Sponsored by
Millet Roux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Herbal, Phytotherapy, Passiflora, Valeriana, Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • HAM-A scale > 30
  • Psychotherapy

Sites / Locations

  • Clinical Pharmacology Unit - Unifac

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Passiflora, Anxiety Disorders

Valeriane, Anxiety Disorder

Arm Description

1 tablet Passiflora;Crataegus;Salix; PO;BID

1 tablet Valeriana officinalis, PO, BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 8, 2010
Last Updated
August 9, 2010
Sponsor
Millet Roux
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1. Study Identification

Unique Protocol Identification Number
NCT01178632
Brief Title
Therapeutic Effect of an Herbal Medicine on Anxiety
Official Title
A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Millet Roux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Herbal, Phytotherapy, Passiflora, Valeriana, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Passiflora, Anxiety Disorders
Arm Type
Experimental
Arm Description
1 tablet Passiflora;Crataegus;Salix; PO;BID
Arm Title
Valeriane, Anxiety Disorder
Arm Type
Active Comparator
Arm Description
1 tablet Valeriana officinalis, PO, BID
Intervention Type
Drug
Intervention Name(s)
Passiflora
Other Intervention Name(s)
PASSIFLORINE
Intervention Description
01 tablet Passiflora p.o., b.i.d.
Intervention Type
Drug
Intervention Name(s)
Valeriana officinalis
Other Intervention Name(s)
VALERIANE
Intervention Description
Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
Primary Outcome Measure Information:
Title
Hamilton anxiety scale score
Description
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.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Insomnia gravity index
Description
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.
Time Frame
Four weeks
Title
Clinical global impression rate scale and Patient global evaluation rate scale
Description
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.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of generalized anxiety disorder HAM-A scale > 17 and <30 Exclusion Criteria: HAM-A scale > 30 Psychotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARIA ELISABETE A MORAES, MD, PhD
Phone
5585-32232903
Email
betemora@matrix.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA ELISABETE A MORAES, MD, PhD
Organizational Affiliation
CLINICAL PHARMACOLOGY UNIT - UNIFAC
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology Unit - Unifac
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-270
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIA ELISABETE A MORAES, MD, PhD
First Name & Middle Initial & Last Name & Degree
ALEXANDRE AQUINO CAMARA, MD

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
ANXIETY DISORDERS
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
Passion Flower
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
Valeriana officinalis

Learn more about this trial

Therapeutic Effect of an Herbal Medicine on Anxiety

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