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临床试验/ITMCTR2000003696
ITMCTR2000003696尚未招募1 期

A randomized, double-blind, placebo-controlled clinical trial of Huaizhen Yanggan capsule in the treatment of knee osteoarthritis

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 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
尚未招募
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
40 至 70(—)
性别
All

入选标准

  • (1) Patients with knee osteoarthritis who meet the diagnostic criteria of Western medicine and TCM syndrome differentiation;
  • (2) Aged 40-70 years old male and female;
  • (3) KL grade was 0-3;
  • (4) VAS score >=4;
  • (5) The subjects had informed consent and signed the informed consent voluntarily.

排除标准

  • (1) KL grade 4;
  • (2) Other inflammatory and painful diseases of knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, tumor, joint trauma, suppurative arthritis, etc;
  • (3) Knee osteoarthritis caused by osteomyelitis, bone tumor and bone tuberculosis;
  • (4) Patients with pyogenic and nonspecific infectious knee osteoarthritis were found;
  • (5) The patients with advanced joint deformity or disability;
  • (6) Intra articular treatment including intra-articular injection of drugs, intra-articular irrigation and arthroscopic surgery were performed within 3 months before the trial;
  • (7) Patients with multiple lower extremity osteoarthritis of hip, knee and ankle had lower limb pain due to the onset of lumbar degenerative disease;
  • (8) Alt >=1.5 ULN, abnormal Cr contration;
  • (9) Pregnant or lactating women;
  • (10) People with allergic constitution or allergic to this drug;
  • (11) Patients with severe cardiovascular and cerebrovascular diseases, blood system, liver, gastrointestinal tract, kidney disease and diabetes mellitus;
  • (12) Mental patients;
  • (13) Those who have used hormone therapy within one month;
  • (14) Those who have used other drugs for the treatment of knee osteoarthritis within one week before the trial, such as non steroidal anti-inflammatory drugs, benzothiazides, glucosamine, chondroitin sulfate and related traditional Chinese medicine;
  • (15) Long term use of other drugs that affect the efficacy and safety of the trial drug and take comprehensive treatment;
  • (16) Patients who have participated in other clinical trials within three months;
  • (17) The researchers consider that it is not suitable to participate in this experiment.

研究者

发起方
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

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