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临床试验/ITMCTR2100004381
ITMCTR2100004381招募中1 期

Research on key generic technologies and application of community prevention and control of chronic diseases related to phlegm and blood stasis

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新:

试验速览

阶段
1 期
状态
招募中
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 80(—)
性别
All

入选标准

  • 1. Aged 40-80 years, male or female;
  • 2. According to the Guidelines for Diagnosis and Treatment of Arteriosclerosis Occlusion of Lower Limb published by Vascular Surgery Group of Chinese Medical Association in 2016, the patients who meet the diagnostic criteria for Arteriosclerosis Occlusion of Lower Limb, as judged by the researchers, are:
  • (1) Older than 40 years;
  • (2) Smoking, diabetes, hypertension, hyperlipidemia and other high risk factors;
  • (3) Clinical manifestations of ASO in lower limbs;
  • (4) The pulsation of the distal artery of the lower limb was weakened or disappeared;
  • (5) Ankle-brachial index <= 0.9;
  • (6) Color Doppler ultrasonography, CTA, MRA, DSA and other imaging examinations showed stenosis or occlusion of the corresponding arteries.
  • Instruction :(1) ~ (4) are necessary items. Ankle-brachial index and color ultrasound can determine the degree of lower limb ischemia.
  • 3. The stenosis of the lower limb artery is more than 50% confirmed by CT examination;
  • 4. Ankle-brachial index > 0.4 and <= 0.9, and no severe ulcers and gangrene in the limbs;
  • 5. Patients in Stage IIA, IIb and III according to Fontaine stage;
  • 6. Patients who need to be enrolled immediately according to the main symptoms in the Clinical Diagnosis Item of Heat Retention Blood Vessel Syndrome of Lower Limb Arteriosclerosis Occlusive Syndrome developed by our research group, combined with tongue and pulse symptoms, and judged by the researchers;
  • 7. Patients who have not received endoscopic treatment and/or surgical treatment;
  • 8. Signed the informed consent and volunteered to participate in the study.

排除标准

  • 1. Patients with severe heart, severe liver (ALT or AST > 2 times the upper limit of normal value), and kidney (Cr > limit of normal value) dysfunction;
  • 2. Complicated with immune diseases, malignant tumor diseases, mental diseases or other serious diseases affecting survival;
  • 3. Patients with severe cognitive impairment or mental disorder, unable to complete the subject's knowledge, unable to cooperate with clinical treatment and evaluation;
  • 4. Pregnant or lactating women, or patients who intend to have children during the study period;
  • 5. Participated in or is participating in other clinical trials within the last three months;
  • 6. Patients who need to take Gansui, Jingdaji, Haizao, Yuanhua and Lilu during the treatment;
  • 7. Patients unsuitable for inclusion or unsuitable for other reasons as determined by the researcher.

研究者

发起方
Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

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