An interventional study of Acupuncture and Mecobalamin in Diabetic Cardiovascular Autonomic Neuropathy, Type 2 Diabetes Mellitus and Diabetic Neuropathies, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Treatment
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
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard glucose-lowering treatment plus oral mecobalamin 0.5 mg three times daily, and acupuncture at Xinshu (BL15), Jueyinshu (BL14) and Yishu (EX-B3) with 15-minute needle retention, 3 times a week for 6 weeks.
Procedure: Acupuncture · Drug: Mecobalamin
Standard glucose-lowering treatment plus oral mecobalamin 0.5 mg three times daily for 6 weeks, without acupuncture.
Drug: Mecobalamin
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.
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.
Total Clinical Effective Rate Based on TCM Syndrome Score
The TCM syndrome score assesses 10 symptoms: palpitations, severe palpitations, chest tightness and chest pain, fatigue, thirst, red tongue with thin pulse, soreness and weakness of the lower back and knees, spontaneous sweating and night sweats, dizziness and insomnia, and limb numbness. Each item is scored 0 to 3, for a total score of 0 to 27; higher scores mean more severe symptoms. Response is defined by the reduction in total score from baseline: markedly effective, a reduction of more than 15 points; effective, a reduction of 5 to 15 points; ineffective, a reduction of less than 5 points. Total effective rate = markedly effective rate + effective rate.
Time frame: Baseline and week 6
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →