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

Marjan

Status and phase: Completed; Phase 3

Conditions: Anxiety Disorder

Treatments: Drug: Passiflora ; Crataegus and Salix; Drug: Valeriana

Study type: Interventional

Funder types: Industry

Identifiers

NCT00794456

MJ 3002-08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Passiflora ; Crataegus and Salix

2

Active Comparator group

Description:

Valeriana officinalis 50 mg

Treatment:

Drug: Valeriana