Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-10-31

Brief Summary

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Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be followed by a post treatment visit.

Hamilton anxiety scale will be used to assess anxiety.

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Detailed Description

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Passiflora incarnata L; Crataegus Oxyacantha L are plant-derived treatment widely used to treat anxiety disorders. This study will compare the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L for the treatment of mild and moderate anxiety. 150 participants will be randomly assigned to receive the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. or Valeriana officinalis for 6 weeks. A post treatment visit will be done 2 weeks for safety evaluation.

Primary outcome: Hamilton anxiety (HAM-A) scale Secondary outcome: Insomnia quality index, Global clinical impression and patients global evaluation scales.

Side effects will be monitorized throughout the study.

Conditions

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Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.

Group Type EXPERIMENTAL

Passiflora ; Crataegus and Salix

Intervention Type DRUG

1 tablet PO twice a day

2

Valeriana officinalis 50 mg

Group Type ACTIVE_COMPARATOR

Valeriana

Intervention Type DRUG

1 tablet PO twice a day

Interventions

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Passiflora ; Crataegus and Salix

1 tablet PO twice a day

Intervention Type DRUG

Valeriana

1 tablet PO twice a day

Intervention Type DRUG

Other Intervention Names

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Pasalix Valeriana officinalis 50 mg

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* hypersensibility to any component
* patients with depression, schizophrenia ou suicidal ideas
* pregnant ou lactating
* heart, liver, lung or kidney important condition
* use of digitalis, AAS, anticoagulants agents, drugs with sedative or antidepressant action
* psychotherapy
* drug or alcohol dependence
* gastrointestinal ulcer history
* hyperthyroidism
* neoplasia
* coagulation disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No