Therapeutic Effect of an Herbal Medicine on Anxiety
キーワード
概要
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
介入/治療
Drug: Passiflora, Anxiety Disorders
Drug: Valeriane, Anxiety Disorder
段階
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]
二次的な結果の測定
1. Insomnia gravity index [Four weeks]
2. Clinical global impression rate scale and Patient global evaluation rate scale [Four weeks]