Anxiety Disorders
Conditions
Keywords
Herbal, Phytotherapy, Passiflora, Valeriana, Anxiety
Brief summary
Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.
Detailed description
The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks. The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A). Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?
Interventions
DRUGPassiflora
01 tablet Passiflora p.o., b.i.d.
DRUGValeriana officinalis
Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
Sponsors
Millet Roux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of generalized anxiety disorder * HAM-A scale \> 17 and \<30
Exclusion criteria
* HAM-A scale \> 30 * Psychotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton anxiety scale score | Four weeks | The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia gravity index | Four weeks | The secondary outcome measure for effectiveness will be the score of the Insomnia gravity index. This questionnaire will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time. |
| Clinical global impression rate scale and Patient global evaluation rate scale | Four weeks | The other secondary outcome measure for effectiveness will be the clinical global impression rate scale and patient global evaluation rate scale. These scales will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time. |
Countries
Brazil
Contacts
Primary ContactMARIA ELISABETE A MORAES, MD, PhD
Outcome results
None listed