Anxiety Disorder Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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