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临床试验/NCT02286453
NCT02286453已完成2 期

Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)

Thammasat University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
84
试验地点
1
主要终点
Pain score

研究概览

简要总结

Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary osteoarthritis of knee with grade I-III of Kellgren & Lawrence criteria
  • Not during breast feeding
  • Not during pregnancy with a good contraception
  • Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
  • Do not abuse drugs
  • Good cooperation

排除标准

  • History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
  • History of allergy diclofenac or allergy herbal medicine

研究组 & 干预措施

1

Experimental

Benjakul

干预措施: Benjakul recipe (Drug)

2

Active Comparator

diclofenac

干预措施: diclofenac (Drug)

结局指标

主要结局

Pain score

时间窗: 28 days

Pain score from Visual analog scale

次要结局

  • Pain score(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patamaporn Rachawat

Piya Pinsornsak

Thammasat University

研究点 (1)

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