Diabetic peripheral neuropathy (DPN)
Conditions
Interventions
Control group:Epalrestat Tablets
Experimental group:Yiqitongluo Decoction
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Western medicine diagnostic criteria: ''Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2021 Edition)'' published by the Diabetes Branch of the Chinese Medical Association: (1) A clear history of diabetes; (2) Neuropathy that occurs at or after the diagnosis of diabetes; (3) The clinical symptoms and signs are consistent with the manifestations of DPN; (4) There are clinical symptoms (pain, numbness, paresthesia, etc.); (5) Any one of the five examinations (ankle reflex, acupuncture pain, vibration, pressure, and temperature) is abnormal; for those without clinical symptoms, any two of the five examinations are abnormal, and the clinical diagnosis is DPN. 2. TCM syndrome diagnosis criteria: refer to the ''Guidelines for Diabetic Peripheral Neuropathy Combination Diagnosis and Treatment of Diabetic Peripheral Neuropathy'' issued by the Endocrinology and Metabolic Medicine Professional Committee of the Chinese Medical Doctor Association Integrative Medicine Physicians Branch in 2021. Standard clinical manifestations of qi deficiency and blood stasis in DPN patients: (1) Consistent with the clinical symptoms and signs of Xiaoke Bi syndrome, numbness of hands and feet, such as ants walking, pain at the end of the limbs, mostly tingling, mainly in the lower limbs, and pain at night; (2) Qi-deficiency group symptoms: fatigue and fatigue, shortness of breath and lazy words, sweating when moving; (3) Qi deficiency and blood stasis tongue and pulse: The tongue is dull, or has petechiae, thin white coating, and thin and astringent pulse. 3. Aged 20-70 years, and the gender is not limited. 4. Informed consent, volunteer subjects, and the process of obtaining informed consent conforms to GCP regulations.
Exclusion criteria
Exclusion criteria: 1. Abnormal liver and kidney function, blood Cr, ALT, AST, BUN exceeding 2.5 times the normal value. 2. Complicated with hypertension that has not been effectively controlled, severe heart, brain, liver, kidney and other organ diseases, as well as blood system diseases or tumors. 3. Those who take the following medicines, such as: Danshen dripping pills, puerarin, astragalus and other traditional Chinese medicine preparations, western medicines such as hormones, and medicines containing the above ingredients. 4. After the onset of the disease, other Chinese patent medicines for nourishing qi and promoting blood circulation are being used for the treatment of DNP. 5. Patients whose blood glucose and other indicators significantly exceed the average level of the research subjects, or who receive other unconventional treatments that may seriously interfere with the baseline levels of the research subjects. 6. Pregnant and lactating patients. 7. Those with allergic constitution, etc. 8. Mentally or legally disabled patients. 9. Suspect or have a history of alcohol or drug abuse, or other pathologies that reduce the possibility of enrollment or complicate enrollment according to the investigator's judgment, such as frequent changes in the working environment, which are likely to cause loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurosensory and conduction function;Plasma levels of HIF-1, VEGF and EPO;Indicators of tissue hypoxia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood sugar; | — |
Countries
China
Contacts
Public ContactHai Qingshan
Yunnan University of Traditional Chinese Medicine
Outcome results
None listed