Therapeutic Effect of an Herbal Medicine on Anxiety

• Insomnia gravity index [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
  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 [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
  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.

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.

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?

• Drug: Passiflora
  01 tablet Passiflora p.o., b.i.d.
  Other Name: PASSIFLORINE
• Drug: Valeriana officinalis
  Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
  Other Name: VALERIANE

• Experimental: Passiflora, Anxiety Disorders
  1 tablet Passiflora;Crataegus;Salix; PO;BID
  Intervention: Drug: Passiflora
• Active Comparator: Valeriane, Anxiety Disorder
  1 tablet Valeriana officinalis, PO, BID
  Intervention: Drug: Valeriana officinalis

Inclusion Criteria:

• Clinical diagnosis of generalized anxiety disorder
• HAM-A scale > 17 and <30

Exclusion Criteria:

• HAM-A scale > 30
• Psychotherapy