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The efficacy and safety of HJ11 granules for Arteriosclerosis obliterans (Heat Retention Blood Vessel Syndrome): a clinical exploratory trial

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043056
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-07-30
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriosclerosis obliteran

Interventions

Sponsors

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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 0.4 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Claudication distance;Arteriosclerosis indicators (dorsal arterial blood flow, ankle humeral index, toe humeral index);Hemodynamic indicators (fibrinogen, whole blood viscosity, plasma viscosity);hs-CRP, IL-6, TNF-a, ß2-M;VascuQol Questionnaire;

Secondary

MeasureTime frame
Maximum flow velocity of the popliteal artery;IL-1ß, IL-8;D2 polymers;

Countries

China

Contacts

Public ContactHu Jingqing

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

gcp306@126.com+86 13911546633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026