Therapeutic Effect of an Herbal Medicine on Anxiety

NCT ID: NCT01178632

Last Updated: 2010-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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?

Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Passiflora, Anxiety Disorders

1 tablet Passiflora;Crataegus;Salix; PO;BID

Group Type EXPERIMENTAL

Passiflora

Intervention Type DRUG

01 tablet Passiflora p.o., b.i.d.

Valeriane, Anxiety Disorder

1 tablet Valeriana officinalis, PO, BID

Group Type ACTIVE_COMPARATOR

Valeriana officinalis

Intervention Type DRUG

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

Interventions

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Passiflora

01 tablet Passiflora p.o., b.i.d.

Intervention Type DRUG

Valeriana officinalis

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

Intervention Type DRUG

Other Intervention Names

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PASSIFLORINE VALERIANE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* HAM-A scale \> 30
* Psychotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millet Roux

INDUSTRY

Sponsor Role lead

Responsible Party

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MILLET ROUX

Principal Investigators

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MARIA ELISABETE A MORAES, MD, PhD

Role: STUDY_DIRECTOR

CLINICAL PHARMACOLOGY UNIT - UNIFAC

Locations

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Clinical Pharmacology Unit - Unifac

Fortaleza, Ceará, Brazil

Site Status

Countries

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Brazil

Central Contacts

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MARIA ELISABETE A MORAES, MD, PhD

Role: CONTACT

5585-32232903

Related Links

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Other Identifiers

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MR4009

Identifier Type: -

Identifier Source: org_study_id

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