Clinical trial NCT00794456: Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Official title: Double Blind, Randomized Study, Controlled by Valeriana Officinalis, of Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Patients With Mild and Moderate Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorder
Keywords: Passiflora
Crataegus
Herbal
Valeriana
anxiety
Lead sponsor: Marjan Industria e Comercio ltda
Sponsor class: INDUSTRY
First posted: 2008-11-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton anxiety scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Insomnia gravity index; global clinical impression; patients global evaluation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Unidade de Farmacologia Clínica - UNIFAC
state: Ceará
city: Sao Paulo
country: Brazil
facility: SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
Study officials:
affiliation: Federal University of Ceará
name: Maria Elisabete A Moraes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Sao Paulo - UNIFESP / DPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
name: Antonio C Lopes, Phd
role: PRINCIPAL_INVESTIGATOR
References: