Diabetic Peripheral NeuropathyNCT06330233
Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study
A study testing Moxibustion in people with Diabetic Peripheral Neuropathy and Pain, run by Zhejiang Chinese Medical University at 3 sites in China.
Trial summary
This study aims to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and a reference for clinical treatment of DPN moxibustion. Patients will be randomly assigned to 3 clinical centers, 30 in each center, and then equally divided into 3 groups, including a drug treatment group, a 15-minute… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Pain, Moxibustion
- What is being tested?
- Moxibustion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of diabetes mellitus;
- Persistent pain and/or abnormal sensation in the extremities (at least in both lower limbs), decreased bilateral or unilateral ankle reflexes, decreased vibratory sensation (weaker in the medial ankle than in the medial tibial condyle), and decreased nerve conduction velocity on the affected side, and TCSS score >5;
- 18 years ≤ age ≤ 80 years;
- Gender is not limited;
- Those who have the ability of independent daily life and can cooperate to complete all the examinations;
- Those who are conscious without serious mental diseases and cognitive disorders, and those who do not have serious cardiac, cerebral, hepatic, renal and other internal diseases;
- Voluntary participation and signing of informed consent.
Who cannot join
- Those with peripheral neuropathy, ulcers and gangrene of the limbs caused by various other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or those with a history of skin ulcers or lesions that do not heal easily;
- Women who are in preparation for pregnancy, during pregnancy or breastfeeding;
- Those with acute complications such as combined diabetic ketoacidosis, lactic acidosis, severe infections, etc.;
- Those who suffer from serious liver or kidney damage or serious cardiovascular and cerebrovascular diseases (angina pectoris, myocardial infarction, multiple cerebral infarctions, cerebral haemorrhage, etc.);
- Those who have scars or pigmentation on the skin of the testing site, which will affect the accuracy of the test;
- Those who are participating in other acupuncture or drug clinical trials.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The First Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, 310000
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Zhejiang Greentown Cardiovascular Hospital
Hangzhou, Zhejiang, 310000
About this study
Official title: Construction of Key Technology and Study of the Effect Mechanism of Moxibustion in the Treatment of Diabetic Peripheral Neuropathy Based on Optimal Selection of Acupoints and Moxibustion Volume
This study aims to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and a reference for clinical treatment of DPN moxibustion. Patients will be randomly assigned to 3 clinical centers, 30 in each center, and then equally divided into 3 groups, including a drug treatment group, a 15-minute moxibustion group, and a 30-minute moxibustion group. Patients in the drug treatment group were given mecobalamin tablets and epalrestat at the same time of daily treatment (hypertension and hyperlipidemia combined with basic drug treatment) for 4 weeks. The frequency of moxibustion was 15/30 minutes per acupoint twice a week for 4 weeks. The results were evaluated during the baseline period (the day before the grouping), the treatment period (the end of the 8th treatment), and the follow-up period (a month after the end of treatment). The results of this part are expected to confirm the therapeutic effect of moxibustion on diabetic peripheral neuropathy. The results of this part will be expected to confirm the optimal amount of moxibustion in the treatment of diabetic peripheral neuralgia and provide a reference for the standardization of clinical treatment of moxibustion.
- Being tested
- Moxibustion
- Keywords
- Diabetic Peripheral Neuropathy, Pain, Moxibustion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionOther
The recruited patients all received diabetes mellitus education. Patients with combined hypertension and hyperlipidemia received daily treatment to lower their blood pressure and blood lipids. The medication was based on their current self-medication, to keep their conditions under normal control. The drug treatment group received mecobalamin tablets and epalrestat orally for four weeks along with their daily treatment. Moxibustion 15-minute group: The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11), and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. The moxibustion 30-minute group except for the operating time will use the same intervention as above.
| Study group | Role | What they receive |
|---|---|---|
| Drug treatment group | Sham comparator | mecobalamin tablets (0.5 mg/dose, 3 times/day) and epalrestat (0.5g/, 3 times/day, before meal) were administered orally for four weeks in conjunction with the patient's daily treatment (basal medication treatment for patients with combined hypertension and hyperlipidemia). Receives: Other: Moxibustion |
| Moxibustion 15 minutes group | Experimental | The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11) and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. Receives: Other: Moxibustion |
| Moxibustion 30 minutes group | Experimental | The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11) and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 30 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. Receives: Other: Moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clinical effectiveness
Overall clinical effectiveness was assessed at 2 time points: after 4 weeks of treatment and during the follow-up period (the 6th week). It was classified into the following 3 grades according to the Guidelines for Clinical Study of New Chinese Medicines:
- Cure: clinical symptoms such as limb numbness, coldness and chilling pain, sensory abnormalities, muscle weakness and muscle atrophy disappear, tendon reflexes return to normal, and the total score of TCSS is ≤ 5 points;
- Effective: numbness of the limbs, cold and chilling pain, sensory abnormalities, muscle weakness myasthenia and other clinical symptoms significantly improved, tendon reflexes returned to normal, TCSS score level 2 or 1 level lower;
- Ineffective: clinical symptoms did not improve or worsen, tendon reflexes were not elicited, and TCSS score grade did not decrease or increase.
Total effective rate = [(number of cured cases + number of effective cases)/total number of cases] × 100%.
Measured: After treatment phase (the 4th week) and the follow-up period (the 5th-8th week)
Secondary outcomes (6)
Electrophysiological examination of the tibial nerve of the lower limb
The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the tibial nerve of the lower extremities were measured by electrophysiological examination before and after treatment.
Measured: Baseline (week 0) and the 4th week
Electrophysiological examination of the peroneal nerve of the lower limb
The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the peroneal nerve of the lower extremities were measured by electrophysiological examination before and after treatment.
Measured: The week 0 and the 4th week
Toronto Clinical Scoring System
The TCSS is a valid instrument to reflect the presence and severity of diabetic peripheral sensorimotor polyneuropathy as measured by sural nerve morphology and electrophysiology16. TCSS scores of 6-8 for mild DPN, 9-10 for moderate DPN, and 12-19 for sev
Measured: The week 0, the 4th week and the 5th-8th week
Visual Analogue Scale
The level of pain at the subject's lesion site will be determined using the VAS scale, which classifies pain on a scale of 0-10, with the greater the number the more pronounced the pain, i.e., a score of 0 indicates no pain, 2-4 represents mild pain, 5-7 represents moderate pain, 8-9 represents severe pain, and 10 represents severe pain. Allow the subject to indicate the level of pain by crossing out specific numbers on the scale according to their actual situation.
Measured: The week 0, the 4th week and the 5th-8th week
Traditional Chinese Medicine Syndrome Score Scale
The evaluation of the curative effect of TCM symptoms should refer to the guiding principles of clinical research of new drugs of traditional Chinese medicine and the clinical evidence-based practice guide of traditional Chinese medicine for diabetes.
The specific records are as follows: 1 the VAS score of limb pain was consistent according to the severity. (2) the three main TCM syndromes of limb numbness, abnormal chill (or fever) and ant feeling were scored as 0, 1, 2 and 3 points respectively according to their severity.
Measured: The week 0, the 4th week and the 5th-8th week
infrared thermography testing
Infrared thermography testing will be performed once before treatment (baseline) and once after 4 weeks of treatment at 2 time points. The test sites will be bilateral plantar, dorsal, palmar, and dorsal hands. The instrument used is the NECR450 infrared thermal imager produced by NECAVIO Company in Japan.
Measured: The week 0 and the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Sep 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Greentown Cardiovascular Hospital
- Responsible party
- Principal investigator, Yongliang Jiang, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330233
- Sponsor's protocol ID
- YJiang
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kang Y, Hu H, Lin C, Zheng Y, Jiang M, Wei Z, He X, Fang J, Jiang Y. Comparative efficacy of moxibustion as an add-on treatment with different durations for diabetic peripheral neuropathy: study protocol for a randomized controlled trial. Front Neurol. 2025 Aug 29;16:1609674. doi: 10.3389/fneur.2025.1609674. eCollection 2025.
PubMed 40948634
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Key Technology and Study of the Effect Mechanism of Moxibustion in the Treatment of Diabetic Peripheral Neuropathy Based on Optimal Selection of Acupoints and Moxibustion Volume
- ClinicalTrials.gov ID
- NCT06330233
- Acronym / sponsor ID
- YJiang
- Keywords
- Diabetic Peripheral Neuropathy, Pain, Moxibustion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Collaborators
- The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Greentown Cardiovascular Hospital
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Mar 2024 (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.
This study aims to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and a reference for clinical treatment of DPN moxibustion. Patients will be randomly assigned to 3 clinical centers, 30 in each center, and then equally divided into 3 groups, including a drug treatment group, a 15-minute moxibustion group, and a 30-minute moxibustion group. Patients in the drug treatment group were given mecobalamin tablets and epalrestat at the same time of daily treatment (hypertension and hyperlipidemia combined with basic drug treatment) for 4 weeks. The frequency of moxibustion was 15/30 minutes per acupoint twice a week for 4 weeks. The results were evaluated during the baseline period (the day before the grouping), the treatment period (the end of the 8th treatment), and the follow-up period (a month after the end of treatment). The results of this part are expected to confirm the therapeutic effect of moxibustion on diabetic peripheral neuropathy. The results of this part will be expected to confirm the optimal amount of moxibustion in the treatment of diabetic peripheral neuralgia and provide a reference for the standardization of clinical treatment of moxibustion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug treatment group | Sham comparator | Other: Moxibustionmecobalamin tablets (0.5 mg/dose, 3 times/day) and epalrestat (0.5g/, 3 times/day, before meal) were administered orally for four weeks in conjunction with the patient's daily treatment (basal medication treatment for patients with combined hypertension and hyperlipidemia). |
| Moxibustion 15 minutes group | Experimental | Other: MoxibustionThe selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11) and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. |
| Moxibustion 30 minutes group | Experimental | Other: MoxibustionThe selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11) and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 30 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of diabetes mellitus;
- Persistent pain and/or abnormal sensation in the extremities (at least in both lower limbs), decreased bilateral or unilateral ankle reflexes, decreased vibratory sensation (weaker in the medial ankle than in the medial tibial condyle), and decreased nerve conduction velocity on the affected side, and TCSS score >5;
- 18 years ≤ age ≤ 80 years;
- Gender is not limited;
- Those who have the ability of independent daily life and can cooperate to complete all the examinations;
Key exclusion criteria (6 listed)
- Those with peripheral neuropathy, ulcers and gangrene of the limbs caused by various other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or those with a history of skin ulcers or lesions that do not heal easily;
- Women who are in preparation for pregnancy, during pregnancy or breastfeeding;
- Those with acute complications such as combined diabetic ketoacidosis, lactic acidosis, severe infections, etc.;
- Those who suffer from serious liver or kidney damage or serious cardiovascular and cerebrovascular diseases (angina pectoris, myocardial infarction, multiple cerebral infarctions, cerebral haemorrhage, etc.);
- Those who have scars or pigmentation on the skin of the testing site, which will affect the accuracy of the test;
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 |
|---|---|---|
| MoxibustionThe recruited patients all received diabetes mellitus education. Patients with combined hypertension and hyperlipidemia received daily treatment to lower their blood pressure and blood lipids. The medication was based on their current self-medication, to keep their conditions under normal control. The drug treatment group received mecobalamin tablets and epalrestat orally for four weeks along with their daily treatment. Moxibustion 15-minute group: The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11), and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. The moxibustion 30-minute group except for the operating time will use the same intervention as above. | Other | Drug treatment group, Moxibustion 15 minutes group, Moxibustion 30 minutes group |
Primary outcome
Total clinical effectiveness
Time frame: After treatment phase (the 4th week) and the follow-up period (the 5th-8th week)
Overall clinical effectiveness was assessed at 2 time points: after 4 weeks of treatment and during the follow-up period (the 6th week). It was classified into the following 3 grades according to the Guidelines for Clinical Study of New Chinese Medicines: 1. Cure: clinical symptoms such as limb numbness, coldness and chilling pain, sensory abnormalities, muscle weakness and muscle atrophy disappear, tendon reflexes return to normal, and the total score of TCSS is ≤ 5 points; 2. Effective: numbness of the limbs, cold and chilling pain, sensory abnormalities, muscle weakness myasthenia and other clinical symptoms significantly improved, tendon reflexes returned to normal, TCSS score level 2 or 1 level lower; 3. Ineffective: clinical symptoms did not improve or worsen, tendon reflexes were not elicited, and TCSS score grade did not decrease or increase. Total effective rate = [(number of cured cases + number of effective cases)/total number of cases] × 100%.
6 secondary outcomes
Electrophysiological examination of the tibial nerve of the lower limb
Time frame: Baseline (week 0) and the 4th week
Electrophysiological examination of the peroneal nerve of the lower limb
Time frame: The week 0 and the 4th week
Toronto Clinical Scoring System
Time frame: The week 0, the 4th week and the 5th-8th week
Visual Analogue Scale
Time frame: The week 0, the 4th week and the 5th-8th week
Traditional Chinese Medicine Syndrome Score Scale
Time frame: The week 0, the 4th week and the 5th-8th week
infrared thermography testing
Time frame: The week 0 and the 4th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 40948634Kang Y, Hu H, Lin C, Zheng Y, Jiang M, Wei Z, He X, Fang J, Jiang Y. Comparative efficacy of moxibustion as an add-on treatment with different durations for diabetic peripheral neuropathy: study protocol for a randomized controlled trial. Front Neurol. 2025 Aug 29;16:1609674. doi: 10.3389/fneur.2025.1609674. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion in people with Diabetic Peripheral Neuropathy and Pain, run by Zhejiang Chinese Medical University at 3 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total clinical effectiveness (time frame: After treatment phase (the 4th week) and the follow-up period (the 5th-8th week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330233, which also lists 1 linked publication.
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 13 Mar 2025.