Diabetic peripheral neuropathy
Conditions
Interventions
Experimental group:Keluoxin Capsules, 0.5 g per capsule, supplied by Sichuan Jishengtang Pharmaceutical Co., Ltd., shall be administered orally at a dose of four capsules per administration with warm
Control group:Placebo of Keluoxin Capsules, 0.5 g per capsule, supplied by Sichuan Jishengtang Pharmaceutical Co., Ltd., shall be administered orally at a dose of four capsules per administration with
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 .Meeting the diagnostic criteria of Western medicine for type 2 diabetes mellitus (Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020 Edition)) and diabetic peripheral neuropathy (Expert Consensus on the Diagnosis and Treatment of Diabetic Neuropathy (2021 Edition)); 2. Meeting the criteria for the identification of the deficiency of Qi and Yin with blood stasis in traditional Chinese medicine (Guidance Principle of Clinical Study on Traditional Chinese Medicine (for trial implementation) 2002); 3. Aged 18-75 years (including critical value), regardless of gender; 4. Electromyogram showing decreased conduction velocity in at least 2 nerves; 5. 6 <= TCSS <=11; 6. Maintain a stable glucose-lowering, antihypertensive (if any), and lipid-lowering (if any) therapeutic schedule (with stable types and doses of drugs) for at least 30 days, with glycosylated hemoglobin (HbA1c) <= 10% and blood pressure <= 140/90 mmHg, and maintained stable for the past month; besides, the glucose-lowering, antihypertensive (if any), and lipid-lowering (if any) therapeutic schedule shouldn’t be changed throughout the course of the study; 7. Discontinuation two weeks prior to enrollment or without use of other therapeutic drugs aiming at peripheral neuropathy ever before (excluding glucose control drugs); 8. Willingness to use effective contraception from the time of signing the informed consent form until 6 months after the last dose; 9. Voluntary signing of the informed consent form before the start of activities related to this study, and with the ability to understand the procedures and methods of this study, and the willingness to complete this trial in strict compliance with the clinical trial protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with a known or suspected history of allergy to the investigational product or its excipients, or allergic individuals; 2. Patients with serious diseases including cardiovascular, hepatic, pulmonary, renal, or hematopoietic diseases that are not in a stable stage; 3. Patients with acute complications of type 2 diabetes mellitus, diabetic ketosis, diabetic ketoacidosis and severe infections in the last month; 4. Patients with neuropathy from other causes, including long-term alcohol intake, drugs with neurotoxic properties (like chemotherapeutic agents), cervical and lumbar spine diseases (compression, stenosis, degeneration), cerebral infarction, chronic inflammatory demyelinating neuropathy, hereditary neuropathy and vasculitis, infections (like acquired immunodeficiency syndrome) and nerve damage from metabolic toxins brought by renal insufficiency; 5. Patients with severe primary diseases and mental illnesses; 6. Patients whose transaminases are more than two times the upper limit of normal values; 7. Patients with a history of exposure to toxic substances; 8. Pregnant or lactating women or those with a pregnancy plan; 9. Patients taking medication affecting neurological function or peripheral neuropathy medication in the last two weeks; 10. Patients who have participated in another drug clinical trial within 3 months before randomization (meaning those randomized and treated with the investigational product); 11. Others who were judged by the investigator to be inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The between-group difference in the change from baseline in the Toronto Clinical Scoring System Scale at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| The between-group differences in the change from baseline in the Michigan Diabetic Neuropathy Score at Week 12 and Week 24;The between-group differences in the change from baseline in nerve conduction velocity (sensory and motor conduction of the median and common peroneal nerves) at Week 12 and Week 24;The between-group differences in the change from baseline in Traditional Chinese Medicine syndrome scores at Week 12 and Week 24;The between-group differences in the change from baseline in clinical symptom scores at Week 12 and Week 24;The between-group difference in the change from baseline in the Toronto Clinical Scoring System Scale at Week 12;The between-group differences in the changes from baseline in eGFR and UACR at Week 12 and Week 24; | — |
Countries
China
Contacts
Public ContactZhou Guangju
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed