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Therapeutic Evaluation of Fuyuan Tongluo Decoction on Lower Extremity Arteriosclerosis Obliterans with Blood Stasis Syndrome

Therapeutic Evaluation of Fuyuan Tongluo Decoction on Lower Extremity Arteriosclerosis Obliterans with Blood Stasis Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001245
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Lower Extremity Arteriosclerosis Obliterans

Interventions

control group:Fuyuan Tongluo Decoction-Matched Placebo
test group:Fuyuan Tongluo Decoction

Sponsors

Shuguang hospital affiliated to Shanghai university of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the ASO diagnostic criteria. (2) Those whose Rutherford classification belongs to grade I-3 to III. (3) Those who are recognized as blood stasis type in Chinese medicine. (4) 40 < age = 80 years old gender is not limited (for women of childbearing age a pregnancy urine test must be performed the pregnancy test must be negative and the patient must not be breastfeeding at the time of the screening visit). (5) Patients with good compliance and ability to cooperate with treatment and observation.

Exclusion criteria

Exclusion criteria: (1) Those with acute or severe limb ischemia such as lower extremity arterial thrombosis and lower extremity arterial embolism. (2) Those who suffer from other inflammatory vascular diseases such as thromboembolic vasculitis and polyarteritis. (3) Those with other diseases affecting activities such as lower limb shutdown lesions and neuropathy. (4) Patients with severe cardiac cerebral hepatic or renal insufficiency or (and) history of major surgery. (5) Pregnant women nursing mothers and special groups of people with combined mental illness. (6) Those who have allergic reactions to the Chinese medicines used or other adverse reactions.

Design outcomes

Primary

MeasureTime frame
Pain-Free Walking Time;Maximum Walking Time;

Secondary

MeasureTime frame
Lipid Indicators;SF-36 Quality of Life Score;Incidence of ulcers, gangrene and amputations;Chinese Medicine Criteria Score;Walking Impairment Questionnaire;Fibrinogen;Buerger's Test;plasma viscosity;Tumor Necrosis Factor a;Ankle–Brachial Index;high sensitive C Reactive Protein;Restenosis Rate in Patients with Prior Endovascular Intervention;Capillary Refill Test;

Countries

China

Contacts

Public ContactLiu Guobin

Shuguang hospital affiliated to Shanghai university of traditional Chinese medicine

15800885533@163.com15800885533

Outcome results

None listed

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