Type 2 Diabetes Small Fiber Neuropathy
Conditions
Interventions
Control:Mecobalamin tablets, taken orally, 0.5 mg each time, three times a day
Chinese medicine group:Tangshenfang decoction with modifications (1 dose daily, taken twice a day in the morning and evening, taken warm 30 minutes after meals)
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The patient has been diagnosed with2 in Western medicine and in Traditional Chinese Medicine; (2) The patient is between 18 and 75 years of age; (3) The patient has had stable blood sugar control in the past three months with a hemoglobin A1c level below 9.0%; (4) The patient is conscious and able to cooperate with examinations and treatments; (5) The patient has signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Except for methylcobalamin, the patient had received treatment for DPN with alpha-lipoic acid, epalrestat, prostaglandins, levocarnitine hydrochloride, traditional Chinese medicine, and decoctions within 4 weeks prior to enrollment. (2) Neuropathy caused by long-term alcohol consumption and/or other factors. (3) Patients with diabetic ketoacidosis, ketosis acidosis, or severe infections within the past month. (4) Patients with severe primary diseases such as cardiovascular, renal, hepatic, or hematopoietic system disorders; those with serum transaminases exceeding twice the normal value; those with serum creatinine above the normal upper limit; and patients with mental disorders. (5) Pregnant, pre-pregnant, or breastfeeding female patients. (6) History of allergy to multiple medications or components of Shuanshen Formula. (7) History of heavy alcohol consumption and/or use of psychoactive substances, drug use, or family history of such behaviors within the past five years. (8) History of active eye diseases, ocular surgery, glaucoma, acute or chronic keratitis, or long-term wear of contact lenses. (9) Patients who have participated in other clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toronto Clinical Scoring System; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal nerve fiber density per millimeter;Corneal nerve branch density per millimeter;Corneal nerve fiber length per millimeter;Current Sensation Threshold;Fasting Blood Glucose;Fasting C-peptide;Postprandial 2-hour blood glucose;glycated hemoglobin;Total Score of TCM Symptom Rating Scale; | — |
Countries
China
Contacts
Public ContactHao Lu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed