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Acupuncture Plus Mecobalamin for Diabetic Cardiac Autonomic Neuropathy
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
The goal of this clinical trial is to learn whether acupuncture can improve damage to the nerves that control the heart (cardiac autonomic neuropathy) in adults with type 2 diabetes. It will also learn about the safety of this acupuncture treatment. The main questions it aims to answer are: Does acupuncture at three points on the back (Xinshu, Jueyinshu and Yishu), added to standard treatment, improve symptoms such as palpitations, chest tightness, fatigue and numbness? Does it improve test results that measure how well the heart's nerves work? Researchers will compare acupuncture plus mecobalamin (a form of vitamin B12) with mecobalamin alone to see whether adding acupuncture works better. Participants will: Continue their usual diabetes treatment and take mecobalamin tablets by mouth three times a day If assigned to the acupuncture group, receive acupuncture 3 times a week for 6 weeks, about 15 minutes each session Have blood tests, heart nerve function tests and symptom questionnaires at the start of the study and again at week 6
Official title: Efficacy and Safety of Acupuncture at Xinshu (BL15), Jueyinshu (BL14) and Yishu (EX-B3) for Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-05-01
Completion Date
2027-12-30
Last Updated
2026-10-30
Healthy Volunteers
No
Interventions
Acupuncture
Manual acupuncture at three main back-shu points: Xinshu (BL15), Jueyinshu (BL14) and Yishu (EX-B3). The even reinforcing-reducing method is used until deqi (needle sensation) is obtained, and needles are retained for 15 minutes. Treatment is given 3 times a week for 6 weeks, in addition to standard glucose-lowering treatment and oral mecobalamin.
Mecobalamin
Oral mecobalamin tablets, 0.5 mg (1 tablet) three times daily for 6 weeks, given together with standard glucose-lowering treatment (glycemic target HbA1c \< 7.0%). Given to both groups.
Locations (1)
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China