The efficacy and safety of HJ11 granules for Arteriosclerosis obliterans (Heat Retention Blood Vessel Syndrome): a clinical exploratory trial
- Conditions
- Arteriosclerosis obliteran
- Registration Number
- ITMCTR2100004381
- Lead Sponsor
- Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VascuQol Questionnaire;hs-CRP, IL-6, TNF-a, ß2-M;Claudication distance;Arteriosclerosis indicators (dorsal arterial blood flow, ankle humeral index, toe humeral index);Hemodynamic indicators (fibrinogen, whole blood viscosity, plasma viscosity);
- Secondary Outcome Measures
Name Time Method D2 polymers;Maximum flow velocity of the popliteal artery;IL-1ß, IL-8;