Therapeutic Effect of an Herbal Medicine on Anxiety

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状態

スポンサー

Millet Roux

臨床試験: NCT01178632

BioSeek: nct01178632

キーワード

概要

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.

説明

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?

日付

最終確認済み:	07/31/2010
最初に提出された:	08/07/2010
提出された推定登録数:	08/08/2010
最初の投稿:	08/09/2010
最終更新が送信されました:	08/08/2010
最終更新日:	08/09/2010
実際の研究開始日:	09/30/2010
一次完了予定日:	11/30/2011
研究完了予定日:	06/30/2012

状態または病気

Anxiety Disorders

介入/治療

Drug: Passiflora, Anxiety Disorders

Drug: Valeriane, Anxiety Disorder

段階

段階 3

アームグループ

腕	介入/治療
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.

適格基準

研究の対象となる年齢	18 Years に 18 Years
研究に適格な性別	All
健康なボランティアを受け入れる	はい
基準	Inclusion Criteria: - Clinical diagnosis of generalized anxiety disorder - HAM-A scale > 17 and <30 Exclusion Criteria: - HAM-A scale > 30 - Psychotherapy

結果

主な結果の測定

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.

二次的な結果の測定

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

キーワード

passiflorine

ヤナギ

不安

サンザシ属

crataegus rhipidophylla

セイヨウシロヤナギ

カノコソウ属

セイヨウカノコソウ

抗真菌薬

概要

説明

日付

状態または病気

介入/治療

段階

アームグループ

適格基準

結果

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