Status:
UNKNOWN
LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
Lead Sponsor:
China Academy of Chinese Medical Sciences
Conditions:
Diabetic Peripheral Neuropathy
Chinese Medicine
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
Based on network pharmacology, Liuweiluobi Granule was screened to treat diabetes peripheral neuropathy with deficiency of the spleen and kidney and stasis-heat syndrome.In the preliminary animal expe...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Meet the clinical confirmed diagnostic criteria of "diabetic peripheral neuropathy";
- Toronto score ≥ 6 points;
- Meet the Chinese medicine diagnostic criteria of Pi-Shen-Liang-Xu (Deficiency of Pi and Shen) and Yu-Re-Ru-Luo (Collaterals with Stasis and Heat） Zheng (Syndrome) in diabetic peripheral neuropathy;
- Over 18 years old and under 75 years old, regardless of gender and ethnicity;
- Have received basic treatment for diabetes controled with stable blood glucose level (fasting blood glucose: \<7mmol / L; 2h postprandial blood glucose: \<11.1mmol / L; glycated hemoglobin: \<8%);
- Have not taken or stopped taking DPN-related drugs (Mutan granules, Qidan Tongluo granules, pregabalin, duloxetine, etc.) for more than one week;
- Sign the informed consent form with valid telephone contact information.
- Exclusion criteria
- Patients with diabetic ketosis, ketoacidosis or co-infection;
- Patients with known malignant tumors;
- Patients with known severe brain diseases, as cerebral infactions with limited activity；
- Patients with known severe arrhythmias or heart failure over Grade 2 (New York Heart Association), or other known severe heart diseases;
- Patients with known severe kidney impairment (creatinine ≥200ummol/L);
- During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-ALT and/or AST level\> 2 times the upper limit of normal range (ULN);
- Patients with spinal cord injury, cervical and lumbar spine lesions (nervous root compression, spinal stenosis, cervical and lumbar degenerative lesions) or sequelae of cerebrovascular disease, neuromuscular junction or muscle disease;
- Patients with other neuropathy diseases caused by, such as: cerebral infarction, Guillain-Barre syndrome, severe arteriovenous vascular disease (venous embolism, lymphangitis), chronic inflammatory demyelinating polyneuropathy, VitB Deficiency, hypothyroidism, alcoholism, neurotoxicity indused by chemotherapeutic drugs, or metabolic nerve damage caused by renal insufficiency;
- Patients with severe arteriovenous vascular disease (venous embolism, lymphangitis, etc.);
- Patients with epilepsy or mental illness;
- Alcoholics;
- Patients with a history of psychotropic substance abuse;
- Patients with allergies or allergies to any drugs in the trial;
- pregnant women or patients with intention to become pregnant;
- Participated in other clinical trials in the past 1 month;
- Patients would not take drug continuously which could affect the evaluation of efficacy;
- Investigator evaluates as unsuitable to participate in this clinical trial.
Exclusion
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04457531
Start Date
October 26 2020
End Date
December 1 2023
Last Update
November 15 2022
Active Locations (1)
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1
Yuquan Hospital of Tsinghua University
Beijing, Beijing Municipality, China, 100000