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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| Zhejiang Greentown Cardiovascular Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxibustion | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Total effective rate = [(number of cured cases + number of effective cases)/total number of cases] × 100%. | After treatment phase (the 4th week) and the follow-up period (the 5th-8th week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (week 0) and the 4th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang Chinese Medicine University | Hangzhou | Zhejiang | 310000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40948634 | Derived | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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. |
| 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 | 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. | 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. | 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. | The week 0 and the 4th week |
| The Third Affiliated Hospital of Zhejiang Chinese Medical University |
| Hangzhou |
| Zhejiang |
| 310000 |
| China |
| Zhejiang Greentown Cardiovascular Hospital | Hangzhou | Zhejiang | 310000 | China |