Derris Scandens Benth Extract VS Naproxen in Knee OA
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スポンサー
Mahidol University
共同編集者
Ministry of Health, Thailand
臨床試験: NCT00503828
BioSeek: nct00503828
キーワード
概要
Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.
日付
| 最終確認済み: | 05/31/2009 |
| 最初に提出された: | 07/17/2007 |
| 提出された推定登録数: | 07/17/2007 |
| 最初の投稿: | 07/18/2007 |
| 最終更新が送信されました: | 01/10/2010 |
| 最終更新日: | 01/12/2010 |
| 実際の研究開始日: | 06/30/2007 |
| 一次完了予定日: | 02/28/2009 |
| 研究完了予定日: | 02/28/2009 |
状態または病気
Knee Osteoarthritis
介入/治療
Drug: Derris Scandens Benth
Drug: naproxen
段階
段階 3
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: naproxen Naproxen 500 mg/day for 4 weeks | Drug: naproxen Naproxen 500 mg/day for 4 weeks |
| Experimental: Derris Scandens Benth Derris Scandens Benth | Drug: Derris Scandens Benth Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks |
適格基準
| 研究の対象となる年齢 | 50 Years に 50 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: - Age >=50 yr - Known case of primary knee osteoarthritis - WOMAC pain subscale (item1) >= 5 - signed informed consent Exclusion Criteria: - hypersensitive to NSAIDs - history of peptic ulcer or melena - unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction - history of intra-articular injection of knee within 3 months - status post knee replacement |
結果
主な結果の測定
1. WOMAC score [2, 4 weeks]
二次的な結果の測定
1. 6-minute walk, Quality of Life, adverse event [2, 4 weeks]
