LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

Early Phase 1

Recruiting

• Conditions: Diabetic Peripheral Neuropathy; Chinese Medicine; Nerve Conduction
• Interventions: Drug: LiuWeiLuoBi Granule; Other: Standard medical treatment

• Registration Number: NCT04457531
• Lead Sponsor: China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Study Start: 2020-10-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean maximal nerve conduction velocity	12 weeks	Mean maximal conduction velocity of the common peroneal motor nerve (MCV) and sensory nerve (SCV)

Secondary Outcome Measures

Name	Time	Method
HbA1c	Baseline, 4 weeks, 8 weeks and 12 weeks
Changes in the level of aldose reductase	to 12 weeks
Total lipids (TC)	Baseline, 4 weeks, 8 weeks and 12 weeks	Lipid level
triglycerides (TG)	Baseline, 4 weeks, 8 weeks and 12 weeks	Lipid level
high density lipoprotein cholesterol (HDL-C)	Baseline, 4 weeks, 8 weeks and 12 weeks	Lipid level
low density lipid Protein cholesterol (LDL-C).	Baseline, 4 weeks, 8 weeks and 12 weeks	Lipid level
Michigan Diabetic Peripheral Neuropathy Score (MDNS)	Baseline, 4 weeks, 8 weeks and 12 weeks	Michigan Diabetic Peripheral Neuropathy Score (MDNS) is a 46 point clinical score, with score ranging from 0 to 3 (score of 0, normal; 1, mild to moderate; 2, severe and score of 3, absent). The score is more high means a worse outcome.In MDNS vibration, pain, and light touch are assessed with a 128 Hz tuning fork, a pin, and a 10g filament, respectively. The outcome measures were performed by the investigator at baseline and at the eighth week.
Toronto clinical scoring system (TCSS)	Baseline, 4 weeks, 8 weeks and 12 weeks	Toronto clinical scoring system (TCSS) includes three parts: the symptom score of the symptom, the reflection score of the nerve and the evaluation score of the sensory function test. Symptoms include numbness, pain, and needle-like sensation in the lower extremities Feelings of weakness, weakness, instability in walking, and similar symptoms of the upper limbs, such as normal score of 0, 1 point for the presence of corresponding symptoms, a total of 6 points; nerve reflex including ankle reflex and knee reflex, bilateral score, normal score of 0, weakened 1 point, 2 points for disappearance, 8 points in total; sensory function test includes 5 items of pain, temperature, pressure, vibration, and position on the right big toe, 0 points for normal, 1 point for abnormality, 5 points in total With a total score of 19 points. With a score of 0 to 5 do not exist in the DPN, 6 to 8 are mild DPN, 9 to 11 are moderate DPN, 12 to 19 are severe DPN.
Quantitative symptoms scales of DPN in Traditional Chinese medicine	Baseline, 4 weeks, 8 weeks and 12 weeks
Fasting blood glucose	Baseline, 4 weeks, 8 weeks and 12 weeks
2 hrs postprandial blood glucose	Baseline, 4 weeks, 8 weeks and 12 weeks

Trial Locations

Locations (1)

Yuquan Hospital of Tsinghua University; 🇨🇳 Beijing, Beijing, China