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LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathy, Chinese Medicine, Nerve Conduction

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

LiuWeiLuoBi Granule

Standard medical treatment

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Yuquan Hospital of Tsinghua UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

LiuWeiLuoBi Group

Control Group

Arm Description

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

Patients will receive the standard medical treatment for 12 weeks.

Outcomes

Primary Outcome Measures

Mean maximal nerve conduction velocity

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

Secondary Outcome Measures

Michigan Diabetic Peripheral Neuropathy Score (MDNS)

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)

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

HbA1c

Changes in the level of aldose reductase

Fasting blood glucose

2 hrs postprandial blood glucose

Total lipids (TC)

Lipid level

triglycerides (TG)

Lipid level

high density lipoprotein cholesterol (HDL-C)

Lipid level

low density lipid Protein cholesterol (LDL-C).

Lipid level

Full Information

NCT ID

NCT04457531

First Posted

March 15, 2020

Last Updated

November 14, 2022

Sponsor

China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04457531

Brief Title

LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

Official Title

A Randomized Controlled Study of LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 26, 2020 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Peripheral Neuropathy, Chinese Medicine, Nerve Conduction

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LiuWeiLuoBi Group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

Other

Arm Description

Patients will receive the standard medical treatment for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

LiuWeiLuoBi Granule

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard medical treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean maximal nerve conduction velocity

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Michigan Diabetic Peripheral Neuropathy Score (MDNS)

Description

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

Toronto clinical scoring system (TCSS)

Description

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

Quantitative symptoms scales of DPN in Traditional Chinese medicine

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

HbA1c

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

Changes in the level of aldose reductase

Time Frame

to 12 weeks

Title

Fasting blood glucose

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

2 hrs postprandial blood glucose

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

Total lipids (TC)

Description

Lipid level

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

triglycerides (TG)

Description

Lipid level

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

high density lipoprotein cholesterol (HDL-C)

Description

Lipid level

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Title

low density lipid Protein cholesterol (LDL-C).

Description

Lipid level

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

Other Pre-specified Outcome Measures:

Title

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

Description

Amino acids, lipid metabolites, vitamins, neurotransmitters and other metabolites will be analyzed and tested using targeted metabolic analysis.

Time Frame

Baseline, 4 weeks, 8 weeks and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhong Wang, Ph.D

Phone

8610-64093207

zhonw@sina.vip.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qiong Liu, Master

Phone

18612808665

694430355@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhong Wang, Ph.D

Organizational Affiliation

China Academy of Chinese Science

Official's Role

Study Chair

Facility Information:

Facility Name

Yuquan Hospital of Tsinghua University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xingzhong Feng, Ph.D

Fengxz9797@sina.com

12. IPD Sharing Statement

Learn more about this trial

LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy

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