Diabetic peripheral neuropathy
Conditions
Interventions
Drug treatment group:Yiqitongluo Decoction
Positive control group:Epalrestat Tablets
Sponsors
Yunnan Traditional Chinese medicine hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Diagnostic criteria for western medicine: guideline for prevention and treatment of type 2 diabetes mellitus (2021 Edition) published by China Diabetes Association of Chinese Medical Association. A. has a clear history of diabetes mellitus; B. diagnosed diabetic neuropathy; or C., clinical symptoms and signs are consistent with DPN's performance; D. has clinical symptoms (pain, numbness, abnormal sensation, etc.); E.5 examination. (ankle reflex, acupuncture pain, vibration, pressure and temperature) is abnormal in any one item; if there are no clinical symptoms, any two of the five items are abnormal, and the clinical diagnosis is DPN. ? The diagnostic criteria of TCM syndromes: refer to the guidelines for the diagnosis and treatment of diabetic peripheral neuropathy combined with the 2021 issue of Endocrinology and metabolic diseases of Chinese Medical Doctor Association integrated traditional Chinese and Western medicine physicians' branch. The standard clinical manifestations of DPN patients with Qi deficiency and blood stasis type: A. meet the clinical symptoms and signs of Xiaoke Bi syndrome, numbness of hands and feet, pain at the end of limbs, mostly tingling, mainly lower limbs, and very painful at night; b. Qi deficiency syndrome: mental fatigue, shortness of breath, lazy speech, movement leads to sweating; c. Qi deficiency and blood stasis tongue pulse: the tongue is light and dark, or there are ecchymosis spots, the moss is thin and white, and the pulse is thin and astringent. ? The age range is 20-70 years old, regardless of gender. ? Informed consent, voluntary subjects, the process of obtaining informed consent was in accordance with the provisions of GCP.
Exclusion criteria
Exclusion criteria: ? Abnormal liver and kidney function, blood Cr, alt, AST and BUN exceeding the normal value by more than 2.5 times. ? Patients with hypertension not effectively controlled, serious heart, brain, liver, kidney and other organ diseases, as well as blood system diseases or tumors. ? Take the following drugs, such as Danshen dropping pills, puerarin, Astragalus and other traditional Chinese medicine preparations, western drugs containing hormones and drugs containing the above ingredients. ? After the onset of this disease, other Chinese patent medicines for supplementing qi and activating blood circulation for the treatment of DNP are being used. ? Patients whose blood glucose and other indicators significantly exceed the average level of the study object, or receive other unconventional treatment, which may seriously interfere with the baseline level of the study object. ? Pregnant and lactating women. ? Allergic constitution, etc. ? A mentally or legally disabled person. ? Suspected or true history of alcohol and drug abuse, or other diseases that reduce the possibility of enrollment or complicate enrollment according to the judgment of the researcher, such as frequent changes in working environment, which are easy to cause loss of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels of HIF-1, VEGF and EPO;Indicators of tissue hypoxia;Neurosensory and conduction function; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood sugar; | — |
Countries
Chinese
Contacts
Public ContactHai Qingshan
Outcome results
None listed