Therapeutic Effect of an Herbal Medicine on Anxiety

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Ingia / Ingia

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Hali

Wadhamini

Millet Roux

JARIBIO LA KLINIKI: NCT01178632

BioSeek: nct01178632

Maneno muhimu

Kikemikali

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.

Maelezo

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?

Tarehe

Imethibitishwa Mwisho:	07/31/2010
Iliyowasilishwa Kwanza:	08/07/2010
Uandikishaji uliokadiriwa Uliwasilishwa:	08/08/2010
Iliyotumwa Kwanza:	08/09/2010
Sasisho la Mwisho Liliwasilishwa:	08/08/2010
Sasisho la Mwisho Lilichapishwa:	08/09/2010
Tarehe halisi ya kuanza kwa masomo:	09/30/2010
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	11/30/2011
Tarehe ya Kukamilisha Utafiti:	06/30/2012

Hali au ugonjwa

Anxiety Disorders

Uingiliaji / matibabu

Drug: Passiflora, Anxiety Disorders

Drug: Valeriane, Anxiety Disorder

Awamu

Awamu 3

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Passiflora, Anxiety Disorders 1 tablet Passiflora;Crataegus;Salix; PO;BID	Drug: Passiflora, Anxiety Disorders 01 tablet Passiflora p.o., b.i.d.
Active Comparator: Valeriane, Anxiety Disorder 1 tablet Valeriana officinalis, PO, BID	Drug: Valeriane, Anxiety Disorder Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: - Clinical diagnosis of generalized anxiety disorder - HAM-A scale > 17 and <30 Exclusion Criteria: - HAM-A scale > 30 - Psychotherapy

Matokeo

Hatua za Matokeo ya Msingi

1. 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.

Hatua za Matokeo ya Sekondari

1. 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.

2. 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.

Therapeutic Effect of an Herbal Medicine on Anxiety

Maneno muhimu

passiflorine

msafsafi

wasiwasi

crataegus

crataegus rhipidophylla

salix alba

valeriana

valeriana officinalis

antifungal