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Acupuncture Plus Mecobalamin for Diabetic Cardiac Autonomic Neuropathy

RecruitingNAAges 18 Years - 70 YearsAllThe Affiliated Nanjing Drum Tower Hospital of Nan…
NCT07907536 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 we

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18 to 70 years * Diagnosed with type 2 diabetes according to the 1999 WHO diagnostic criteria * Cardiovascular autonomic neuropathy confirmed by cardiovascular autonomic reflex tests (CARTs) Exclusion Criteria: * Acute complications or severe chronic complications of diabetes * Primary cardiomyopathy, such as dilated, hypertrophic, restrictive, arrhythmogenic right ventricular or unclassified cardiomyopathy * Acute cardiovascular disease, such as acute coronary syndrome, pulmonary embolism or ruptured aortic dissection * Acute infection, recent surgery, trauma or other stress states * Use of drugs that affect the heart, such as beta-blockers, atropine or digitalis, within the past 2 weeks * Use of alcohol, caffeine or sedatives within the past 24 hours * Severe heart, liver, lung or kidney insufficiency, or a history of malignancy * Diseases other than type 2 diabetes that may cause neuropathy, including: metabolic diseases (thyroid dysfunction, hypertriglyceridemia, amyloidosis); connective tissue diseases; inflammatory neurovascular diseases (Guillain-Barre syndrome, polyradiculopathy, cerebral infarction); psychiatric disorders (anxiety, depression, schizophrenia); nutritional deficiencies (vitamin B6, B12, E, etc.); alcohol dependence; exposure to neurotoxic agents (chemotherapy drugs, heavy metals, chemical products); and chronic infectious diseases (hepatitis B, syphilis, HIV infection) * Unable to cooperate with testing because of cognitive impairment or intellectual factors
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What it tests

  • Acupuncture
  • Mecobalamin
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Where

1 site
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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