LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

NCT04457531 | Unknown Early Phase 1 DMC

• 1 other identifier: LIUWEI-V1.1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 experiment, it suggested that this granule had a significant protective effect on the peripheral motor nerves of diabetic peripheral neuropathy and the effect of anti-inflammation, and the prescription did not induce the death of zebrafish at a concentration of 1000 ug/mL, without any obvious toxicity. This study aims to evaluate the efficacy of Liuweiluobi Granule in improving neurotransmission function in patients with diabetic peripheral neuropathy through a pilot, randomized controlled study.

Conditions

Diabetic Peripheral Neuropathy; Chinese Medicine; Nerve Conduction

Outcome Measures

Primary Outcomes (1)

• Mean maximal nerve conduction velocity

  Mean maximal conduction velocity of the common peroneal motor nerve (MCV) and sensory nerve (SCV)

  12 weeks

Secondary Outcomes (11)

• Michigan Diabetic Peripheral Neuropathy Score (MDNS)

  Baseline, 4 weeks, 8 weeks and 12 weeks

• Toronto clinical scoring system (TCSS)

  Baseline, 4 weeks, 8 weeks and 12 weeks

• Quantitative symptoms scales of DPN in Traditional Chinese medicine

  Baseline, 4 weeks, 8 weeks and 12 weeks

• HbA1c

  Baseline, 4 weeks, 8 weeks and 12 weeks

• Changes in the level of aldose reductase

  to 12 weeks

Other Outcomes (1)

• Amino acids, lipid metabolites, vitamins, neurotransmitters and other metabolites

  Baseline, 4 weeks, 8 weeks and 12 weeks

Study Arms (2)

LiuWeiLuoBi Group

EXPERIMENTAL

Patients will receive the treatment of LiuWeiLuoBi Granule for 12 weeks,twice a day added to the standard medical treatment.

Drug: LiuWeiLuoBi Granule; Other: Standard medical treatment

Control Group

OTHER

Patients will receive the standard medical treatment for 12 weeks.

Other: Standard medical treatment

Interventions

LiuWeiLuoBi Granule DRUG

LiuWeiLuoBi Granule is a Chinese medicine made from 6 herbal medicine, including Shaji(Sea-buckthorn), Honghua (Safflower), Jinyinhua(Honeysuckle),etc.

LiuWeiLuoBi Group

Standard medical treatment OTHER

Standard medical therapy is adhered to the guidline issued by American Diabetes Association and Chinese Diabetes Society at 2017, including keeping an appropriate diet, doing some exercises, the pharmacological therapy to control the blood glucose, blood pressure and blood lipids.

Control Group; LiuWeiLuoBi Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Yuquan Hospital of Tsinghua University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Study Officials

• Zhong Wang, Ph.D

  China Academy of Chinese Science

  STUDY CHAIR

Central Study Contacts

Zhong Wang, Ph.D

CONTACT

8610-64093207; zhonw@sina.vip.com

Qiong Liu, Master

CONTACT

18612808665; 694430355@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: July 7, 2020
• Study Start: October 26, 2020
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (1)