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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00794456
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Marjan Industria e Comercio ltda

Tracking Information
First Submitted Date  ICMJE November 19, 2008
First Posted Date  ICMJE November 20, 2008
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Hamilton anxiety scale [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Insomnia gravity index; global clinical impression; patients global evaluation [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorder
Intervention  ICMJE
  • Drug: Passiflora ; Crataegus and Salix
    1 tablet PO twice a day
    Other Name: Pasalix
  • Drug: Valeriana
    1 tablet PO twice a day
    Other Name: Valeriana officinalis 50 mg
Study Arms  ICMJE
  • Experimental: 1
    Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
    Intervention: Drug: Passiflora ; Crataegus and Salix
  • Active Comparator: 2
    Valeriana officinalis 50 mg
    Intervention: Drug: Valeriana
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2008)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794456
Other Study ID Numbers  ICMJE MJ 3002-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Marjan Industria e Comercio ltda
Original Responsible Party Janice Mascarenhas Marques, Marjan Industria e Comércio Ltda
Current Study Sponsor  ICMJE Marjan Industria e Comercio ltda
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Elisabete A Moraes, MD Federal University of Ceará
Principal Investigator: Antonio C Lopes, Phd Federal University of Sao Paulo - UNIFESP / DPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
PRS Account Marjan Industria e Comercio ltda
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP