The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis: a Study Protocol for a Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- change of the Western Ontario and McMaster university of orthopedic index
研究概览
简要总结
Knee osteoarthritis (KOA) is known as degenerative joint disease, which is the most common form of arthritis and the leading cause of disability, loss of function and pain worldwide. Effective therapy to manage RA is still lack at present. Fangji Huangqi pill (FHP) is a Chinese medicine which has been widely used in treating KOA in China for hundreds of years to relieve pain, reduce swelling and protect the affected joints from further degeneration. However, no certain evidence to show the effect of FHP for the management of active KOA.
详细描述
A randomized, double-blind, placebo-controlled clinical trials (RCT) will be conducted to explore whether the FHP could relieve pain and protect joints. 200 participants suffering from KOA will be enrolled and treated with FHP or placebo for 1 month. The primary outcome measures are the Visual analogue scale (VAS), Western Ontario and McMaster university of orthopedic index (WOMAC), the Lequesne index, and MOS Sleep Scale would be measured from the baseline to 1 month. The second outcome measures would be the six minutes walking test, the Short Form 36-item Health Survey (SF- 36), the X-ray of both knees, and the adverse events from the baseline to 2 weeks, 4 weeks, and 12 weeks' follow-up. In addition, the VAS score, the WOMAC score, the Lequesne index, and AIS Sleep Scale from the baseline to 2 weeks and 12 weeks' follow-up are also the second outcome measures.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for knee osteoarthritis (American College of Rheumatology criteria)
- •Grade 0-3 on the Kellgren-Lawrence grading system
- •No serious medical history
- •No known drug allergies
- •No steroids, glucosamine, chondroitin sulfate, sodium hyaluronate before Fangji Huangqi pill treatment within 1 month
排除标准
- •Combined with other disease such as rheumatoid arthritis, lupus arthritis and et. al
- •Grade 4 on the Kellgren-Lawrence grading system
- •Allergy to study drug
- •Participating in other clinical trial
- •Unwilling to give informed consent
研究组 & 干预措施
Experimental group
Drug: Fangji Huangqi pill 4g, twice a day, one month, oral Drug: Mobic 7.5mg, once a day, one month, oral participants should administrate both pill and Mobic
干预措施: Fangji Huangqi pill or Fangji Huangqi pill placebo (Drug)
Placebo group
Drug: Fangji Huangqi pill placebo 4g, twice a day, one month, oral Drug: Mobic 7.5mg, once a day, one month, oral participants should administrate both pill placebo and Mobic
干预措施: Fangji Huangqi pill or Fangji Huangqi pill placebo (Drug)
结局指标
主要结局
change of the Western Ontario and McMaster university of orthopedic index
时间窗: at 1 month
change of the visual analogue scale (VAS)
时间窗: at 1 month
change of the 6 minutes walk test
时间窗: at 1 month
change of the Lequesne index
时间窗: at 1 month
次要结局
- change score of the Short Form 36-item Health Survey Questionnaire (SF-36)(from baseline to 12 weeks)
- change of the Western Ontario and McMaster university of orthopedic index(from baseline to 12 weeks)
- change of the visual analogue scale (VAS)(from baseline to 12 weeks)
- change of the Lequesne index(from baseline to 12 weeks)
- change of the 6 minutes walk test(from baseline to 12 weeks)
研究者
Cui xuejun
Clinical research base of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine