Diabetic Peripheral NeuropathyEarly Phase 1NCT04457531
LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
A Early Phase 1 study testing LiuWeiLuoBi Granule and Standard medical treatment in people with Diabetic Peripheral Neuropathy and Chinese Medicine, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Chinese Medicine, Nerve Conduction
- What is being tested?
- LiuWeiLuoBi Granule and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2020to Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuquan Hospital of Tsinghua University
Beijing, Beijing Municipality, 100000
Xingzhong Feng, Ph.D, Fengxz9797@sina.com
About this study
Official title: A Randomized Controlled Study of LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
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.
- Being tested
- LiuWeiLuoBi Granule, Standard medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiuWeiLuoBi GranuleDrug
LiuWeiLuoBi Granule is a Chinese medicine made from 6 herbal medicine, including Shaji(Sea-buckthorn), Honghua (Safflower), Jinyinhua(Honeysuckle),etc.
Standard medical treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LiuWeiLuoBi Group | Experimental | Patients will receive the treatment of LiuWeiLuoBi Granule for 12 weeks,twice a day added to the standard medical treatment. Receives: Drug: LiuWeiLuoBi Granule; Other: Standard medical treatment |
| Control Group | Other | Patients will receive the standard medical treatment for 12 weeks. Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean maximal nerve conduction velocity
Mean maximal conduction velocity of the common peroneal motor nerve (MCV) and sensory nerve (SCV)
Measured: 12 weeks
Secondary outcomes (11)
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
Quantitative symptoms scales of DPN in Traditional Chinese medicine
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
HbA1c
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
Changes in the level of aldose reductase
Measured: to 12 weeks
Fasting blood glucose
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
2 hrs postprandial blood glucose
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
Total lipids (TC)
Lipid level
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
triglycerides (TG)
Lipid level
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
high density lipoprotein cholesterol (HDL-C)
Lipid level
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
low density lipid Protein cholesterol (LDL-C).
Lipid level
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start26 Oct 2020
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Zhong Wang, Ph.D, Study chair, China Academy of Chinese Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457531
- Sponsor's protocol ID
- LIUWEI-V1.1
- Status last verified
- Nov 2022
- First submitted
- 15 Mar 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04457531
- Acronym / sponsor ID
- LIUWEI-V1.1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiuWeiLuoBi Group | Experimental | Drug: LiuWeiLuoBi Granule, Other: Standard medical treatmentPatients will receive the treatment of LiuWeiLuoBi Granule for 12 weeks,twice a day added to the standard medical treatment. |
| Control Group | Other | Other: Standard medical treatmentPatients will receive the standard medical treatment for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%);
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiuWeiLuoBi GranuleLiuWeiLuoBi Granule is a Chinese medicine made from 6 herbal medicine, including Shaji(Sea-buckthorn), Honghua (Safflower), Jinyinhua(Honeysuckle),etc. | Drug | LiuWeiLuoBi Group |
| Standard medical treatmentStandard 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. | Other | Control Group, LiuWeiLuoBi Group |
Primary outcome
Mean maximal nerve conduction velocity
Time frame: 12 weeks
Mean maximal conduction velocity of the common peroneal motor nerve (MCV) and sensory nerve (SCV)
11 secondary outcomes
Michigan Diabetic Peripheral Neuropathy Score (MDNS)
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Toronto clinical scoring system (TCSS)
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Quantitative symptoms scales of DPN in Traditional Chinese medicine
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
HbA1c
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Changes in the level of aldose reductase
Time frame: to 12 weeks
Fasting blood glucose
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
2 hrs postprandial blood glucose
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Total lipids (TC)
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
triglycerides (TG)
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
high density lipoprotein cholesterol (HDL-C)
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
low density lipid Protein cholesterol (LDL-C).
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong Wang, Ph.D study chair
China Academy of Chinese Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LiuWeiLuoBi Granule and Standard medical treatment in people with Diabetic Peripheral Neuropathy and Chinese Medicine, run by China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Wang, Ph.D (8610-64093207, zhonw@sina.vip.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean maximal nerve conduction velocity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.