Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-28 @ 10:38 PM
Study NCT ID:
NCT00794456
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2008-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Sponsor:
Marjan Industria e Comercio ltda
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: