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Clinical evaluation of effectiveness and safety of Yiqi Yangyin Huoxue decoction in the treatment of lower limb arteriosclerosis and vascular aging in T2DM

Clinical evaluation of effectiveness and safety of Yiqi Yangyin Huoxue decoction in the treatment of lower limb arteriosclerosis and vascular aging in T2DM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000388
Enrollment
Unknown
Registered
2024-09-05
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Type 2 diabetes combined with lower extremity atherosclerosis disease

Interventions

control group: Give Yiqi Yangyin and Huoxue compound granules simulator
treatment group:Give Yiqi Yangyin and Huoxue compound granules

Sponsors

Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age =65 and =80 years old no gender limit; (2) Meet the diagnostic criteria for type 2 diabetes and lower limb atherosclerosis; (3) The severity of LEAD belongs to Fontaine stage I-III; (4) Meet the diagnostic criteria of traditional Chinese medicine syndrome of "Qi and Yin deficiency combined with blood stasis"; (5) Voluntarily participate in this study and obtain written informed consent from respiratory patients or authoritative representatives.

Exclusion criteria

Exclusion criteria: (1) Combined with other vascular system diseases or related diseases affecting lower limb activity, such as: thromboangitis, Takayasu arteritis, arterial embolism, Raynaud's disease, lumbar spinal stenosis, etc.; (2) Patients with acute coronary syndrome, severe heart failure (cardiac function class III to IV), cardiomyopathy, and poorly controlled hypertension (systolic blood pressure =180 mmgh or diastolic blood pressure =110 mmgh); (3) Those combined with autoimmune diseases, malignant tumors, radiotherapy and chemotherapy, thyroid and parathyroid diseases, and blood system diseases; (4) Those who have undergone lower limb revascularization within the past year; (5) Obvious liver function damage has occurred in the past 6 months (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 times the upper limit of normal); (6) There are contraindications for 6-minute walking (such as abdominal aortic aneurysm >4cm, heart surgery, myocardial infarction in the past month, unstable angina, resting heart rate >120 beats/min, systolic blood pressure >180mmHg, diastolic pressure>100mmHg); (7) Pregnant and lactating women; (8) Those who are allergic to or have contraindications to the drugs or ingredients in this study; (9) Those who have participated or are participating in other clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Brachial-ankle artery pulse wave velocity;Traditional chinese medicine syndrome score;

Secondary

MeasureTime frame
Traditional Chinese Medicine Symptom Score;Hemoglobin A1c;Six-minute walk test;Vascular quality of life questionnaire-6;Total cholesterol;High-density lipoprotein cholesterol;Fasting plasma glucose;Ankle brachial pressure index;Low-density lipoprotein cholesterol;Triglyceride;

Countries

China

Contacts

Public ContactYing Zhang

Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences

doctoronline@126.com18611862736

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 5, 2026