ITMCTR2000004088已完成1 期
Single-center, randomized, controlled, double-blind clinical study of Huatan Huoxue Decoction for topical treatment of knee osteoarthritis with phlegm and blood stasis
Heping Lane Community Health Service Center0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 50 至 70（—）
- 性别
- All
入选标准
- •1. Western medicine diagnosis: recurrent knee pain in the past month;X-rays (standing or weight-bearing) show narrowing of joint Spaces, subchondral osteosclerosis and/or cystic changes, and joint marginal osteophyte formation;Age >=50 years old; Morning stiffness for 30 min or less;
- •2. TCM syndrome diagnosis: joint pain, swelling hypertropia, with joint hypertropia, limited activity, tongue reddish, thin or greasy tongue coating, pulse slip or string;
- •3. Knee pain such as thorn, VAS pain scale score > 30mm;
- •4. Aged 50 to 70 years old;
- •5. Informed consent has been signed before the test.
- •In addition, if the patient has osteoarthritis of both knees, choose the more severe side.If both knees had the same pain score, one side of the knee was selected for intervention according to study needs.
排除标准
- •(1) Those who do not meet the inclusion criteria;
- •(2) A history of knee trauma or surgery within 6 months;
- •(3) Arthroscopy, arthroscopic surgery, cartilage repair surgery, force line correction surgery and other restorative therapy, intra-articular injection of drugs or knee arthroplasty were performed within 3 months;
- •(4) Who Is participating or is participating in other clinical trials within 3 months;
- •(5) other knee joint diseases, such as patella softening, rheumatoid arthritis or rheumatoid factor (RF) positive (RF>40 U/ml), gout arthritis involving the knee, etc;
- •(6) Kellgren and Lawrence classification level >=III;
- •(7) Not suitable for intermediate frequency treatment, such as acute suppurative inflammation of the knee, bleeding tendency, malignant tumor, active tuberculosis, pacemaker placement, thrombophlebitis, treatment site with metal foreign body, tetanus, etc.;
- •(8) Patients with mental disorders or serious diseases, such as severe diabetes, severe liver and kidney disease, malignant tumors, infectious diseases or complications affecting the joints;
- •(9) Severe hypersensitivity and hypersensitivity to the ingredients of Huatan Huoxue decoction , placebo liquid, and cloth;
- •(10) skin infection, collapse or other skin diseases;
- •(11) Be pregnant or breast-feeding.
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