NCT06330233

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Zhejiang Chinese Medical University · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Moxibustion	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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2024-03-26
• Last updated: 2025-03-13

Locations

3 sites across 1 country: China