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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00794456

Enrollment

150

Registered

2008-11-20

Start date

2009-09-30

Completion date

2013-10-31

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder

Keywords

Passiflora, Crataegus, Herbal, Valeriana, anxiety

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.

Interventions

DRUGPassiflora ; Crataegus and Salix

1 tablet PO twice a day

DRUGValeriana

1 tablet PO twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Hamilton anxiety scale	6 weeks

Secondary

Measure	Time frame
Insomnia gravity index; global clinical impression; patients global evaluation	6 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026