Diabetic peripheral neuropathy
Conditions
Interventions
Traditional Chinese Medicine Observation Group:The patient is taking Iparagazole tablets 50mg three times daily orally as the base treatment, and additionally using Xiaoke Tongbi granules twice daily
Western medicine control group:Take 50 mg of Epalrestat tablets daily, three times a day, orally. For a continuous period of 8 weeks.
Sponsors
Panjin Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Age > 18 years, and meets the diagnostic criteria for Qi deficiency and blood stasis type diabetic peripheral neuropathy in both traditional Chinese medicine (TCM) and Western medicine (see diagnostic criteria), and voluntarily signs the informed consent form for the study. The patients should be diagnosed with type 2 diabetes mellitus. Diagnostic Criteria Western Medical Diagnostic Criteria: 1. Confirmed history of diabetes mellitus (DM); 2. Onset of neuropathy during or after DM diagnosis; 3. Symptoms and signs consistent with diabetic peripheral neuropathy (DPN); 4. For patients with symptoms such as numbness, pain, or sensory abnormalities in the limbs, at least 1 out of 5 tests (ankle reflex, pinprick sensation, vibratory sensation, pressure sensation, temperature sensation) is abnormal; for patients without such symptoms, at least 2 out of 5 tests are abnormal, confirming the diagnosis; 5. Exclude neuropathy caused by other factors (especially when rapid progression, asymmetrical lesion sites, or significant motor function impairment compared to sensory function impairment are present): such as cervical or lumbar spine lesions (nerve root compression, spinal stenosis, degenerative changes of the vertebrae), cerebral infarction, Guillain-Barré syndrome; severe arteriovenous vascular lesions (venous thrombosis, lymphangitis), etc.; neuropathy caused by drug toxicity or impaired renal function leading to metabolic toxins. Traditional Chinese Medical Diagnostic Criteria (Qi deficiency and blood stasis type of Xiao Ke Bi Zheng): 1. Principal symptoms: Limb weakness and numbness as if ants are crawling, intermittent pain in the extremities, mostly stabbing pain, predominantly in the lower limbs, with exacerbation at night. 2. Secondary symptoms: Fatigue, shortness of breath, reluctance to speak, sweating during movement, diarrhea or constipation. 3. Tongue and pulse: Pale dark tongue, or with petechiae, thin white coating, fine and thready pulse. 4. Presence of principal symptoms, accompanied by 2 or more secondary symptoms, combined with tongue and pulse findings, allows for diagnosis.
Exclusion criteria
Exclusion criteria: Exclusion criteria: patients with severe diabetic ketoacidosis or infections, severe diabetic foot gangrene; patients with proliferative diabetic retinopathy; patients who have undergone recent laser surgery; patients with a history of life-threatening conditions such as malignant hypertension, myocardial infarction, or cerebrovascular accidents within the past year, and those with congestive heart failure (NYHA I-IV) who are currently on anticoagulant or antiplatelet medications; patients with tumors, pregnancy, or allergies to treatment drugs, and other conditions unsuitable for this treatment plan; patients with neuropathy caused by other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM Syndrome Score;Toronto Clinical Scoring System; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral nerve conduction velocity;Fasting Blood Glucose;Blood Lipids; | — |
Countries
China
Contacts
Public ContactQiu Shaochen
Panjin Hospital of Traditional Chinese Medicine
Outcome results
None listed