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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00794456
Other study ID # MJ 3002-08
Secondary ID
Status Completed
Phase Phase 3
First received November 19, 2008
Last updated July 7, 2014
Start date September 2009
Est. completion date October 2013

Study information

Verified date July 2014
Source Marjan Industria e Comercio ltda
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Passiflora ; Crataegus and Salix
1 tablet PO twice a day
Valeriana
1 tablet PO twice a day

Locations

Country Name City State
Brazil Unidade de Farmacologia Clínica - UNIFAC Fortaleza Ceará
Brazil SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Marjan Industria e Comercio ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton anxiety scale 6 weeks No
Secondary Insomnia gravity index; global clinical impression; patients global evaluation 6 weeks No
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