Derris Scandens Benth Extract VS Naproxen in Knee OA
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StatusLengkap
Sponsor
Mahidol University
Kolaborator
Ministry of Health, Thailand
UJI KLINIS: NCT00503828
BioSeek: nct00503828
Kata kunci
Abstrak
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.
tanggal
| Terakhir Diverifikasi: | 05/31/2009 |
| Pertama Dikirim: | 07/17/2007 |
| Perkiraan Pendaftaran Telah Dikirim: | 07/17/2007 |
| Pertama Diposting: | 07/18/2007 |
| Pembaruan Terakhir Dikirim: | 01/10/2010 |
| Pembaruan Terakhir Diposting: | 01/12/2010 |
| Tanggal Mulai Studi Sebenarnya: | 06/30/2007 |
| Perkiraan Tanggal Penyelesaian Utama: | 02/28/2009 |
| Perkiraan Tanggal Penyelesaian Studi: | 02/28/2009 |
Kondisi atau penyakit
Knee Osteoarthritis
Intervensi / pengobatan
Drug: Derris Scandens Benth
Drug: naproxen
Tahap
Tahap 3
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| 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 |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 50 Years Untuk 50 Years |
| Jenis Kelamin yang Layak untuk Belajar | All |
| Menerima Relawan Sehat | Iya |
| Kriteria | 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 |
Hasil
Ukuran Hasil Utama
1. WOMAC score [2, 4 weeks]
Ukuran Hasil Sekunder
1. 6-minute walk, Quality of Life, adverse event [2, 4 weeks]
