Efficacy and Safety of Xinfeng Capsule in the Treatment of Knee Osteoarthritis (KOA) :A Randomized, Double-blind, Double-dummy, Multi-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 3
- 主要终点
- Western Ontario and McMaster Osteoarthritis Index (WOMAC)
研究概览
简要总结
Complementary and alternative medicine has been employed over thousands of years to relieve knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may explored its mechanism. However, presently, there is a lack of large-sample, multicenter, randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA. Therefore, the investigators designed a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of KOA.
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
- Triple (Participant, 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
- •Participants must meet the American College of Rheumatology (ACR) 1995 revised criteria for KOA.
- •Participants must be aged between 40 and 75 years.
- •Participants shall not take non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids during the 7 days prior to screening.
- •Participants shall not take Chinese medicine for the treatment of KOA during the 7 days prior to screening.
- •Joint function in the I-III, X-ray stage in the I-III.
- •All participants shall agree to participate in the study and sign an informed consent form.
排除标准
- •Patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity.
- •Patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures.
- •Persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury .
- •Patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases.
- •Pregnant women or breastfeeding mothers or individuals with known psychiatric disorders.
- •Patients who are hypersensitive to the trial medication.
研究组 & 干预措施
Xinfeng capsule
Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks
干预措施: Xinfeng capsule (Drug)
glucosamine sulfate capsule
glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks
干预措施: glucosamine sulfate (Drug)
结局指标
主要结局
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
时间窗: up to week 4
次要结局
- KOA severity using the Lequesne MG score(baseline,week2,week4)
- Bilateral femoral bone mineral density.(baseline,week4)
- Health assessment of the patient refer to the MOS item short from health survey (SF-36)(baseline,week4)
- Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium(baseline,week4)
- Arthritis pain assessment using the Visual Analog scale (VAS)(baseline,week2,week4)
研究者
Liu Jian
professor，Chief Physician
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine