Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Primary Purpose
Anxiety Disorder
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Passiflora ; Crataegus and Salix
Valeriana
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder focused on measuring Passiflora, Crataegus, Herbal, Valeriana, anxiety
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
Sites / Locations
- Unidade de Farmacologia Clínica - UNIFAC
- SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
Valeriana officinalis 50 mg
Outcomes
Primary Outcome Measures
Hamilton anxiety scale
Secondary Outcome Measures
Insomnia gravity index; global clinical impression; patients global evaluation
Full Information
NCT ID
NCT00794456
First Posted
November 19, 2008
Last Updated
July 7, 2014
Sponsor
Marjan Industria e Comercio ltda
1. Study Identification
Unique Protocol Identification Number
NCT00794456
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marjan Industria e Comercio ltda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
Passiflora, Crataegus, Herbal, Valeriana, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Valeriana officinalis 50 mg
Intervention Type
Drug
Intervention Name(s)
Passiflora ; Crataegus and Salix
Other Intervention Name(s)
Pasalix
Intervention Description
1 tablet PO twice a day
Intervention Type
Drug
Intervention Name(s)
Valeriana
Other Intervention Name(s)
Valeriana officinalis 50 mg
Intervention Description
1 tablet PO twice a day
Primary Outcome Measure Information:
Title
Hamilton anxiety scale
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Insomnia gravity index; global clinical impression; patients global evaluation
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisabete A Moraes, MD
Organizational Affiliation
Federal University of Ceará
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio C Lopes, Phd
Organizational Affiliation
Federal University of Sao Paulo - UNIFESP / DPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidade de Farmacologia Clínica - UNIFAC
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-270
Country
Brazil
Facility Name
SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
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