Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study

NCT06330233 | Active Not Recruiting

• 1 other identifier: YJiang
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Diabetic Peripheral Neuropathy; Pain; Moxibustion; Randomized Controlled Trial

Keywords

Diabetic Peripheral Neuropathy; Pain; Moxibustion

Outcome Measures

Primary Outcomes (1)

• 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: 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%.

  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

  Baseline (week 0) and the 4th week

• Electrophysiological examination of the peroneal nerve of the lower limb

  The week 0 and the 4th week

• Toronto Clinical Scoring System

  The week 0, the 4th week and the 5th-8th week

• Visual Analogue Scale

  The week 0, the 4th week and the 5th-8th week

• Traditional Chinese Medicine Syndrome Score Scale

  The week 0, the 4th week and the 5th-8th week

Study Arms (3)

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).

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.

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.

Other: Moxibustion

Interventions

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.

Drug treatment group; Moxibustion 15 minutes group; Moxibustion 30 minutes group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Zhejiang Greentown Cardiovascular Hospital: collaborator

Study Sites (3)

The First Affiliated Hospital of Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, 310000, China

Location

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• 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.

  PMID: 40948634 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 26, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (3)