Diabetic Cardiovascular Autonomic NeuropathyNCT07907536
Acupuncture Plus Mecobalamin for Diabetic Cardiac Autonomic Neuropathy
A study testing Acupuncture and Mecobalamin in people with Diabetic Cardiovascular Autonomic Neuropathy and Type 2 Diabetes Mellitus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Cardiovascular Autonomic Neuropathy, Type 2 Diabetes Mellitus, Diabetic Neuropathies
- What is being tested?
- Acupuncture and Mecobalamin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu
Chenxi Li, +8613951880711, lichenxi@smail.nju.edu.cn
About this study
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
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:
Read more
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
- Conditions
- Diabetic Cardiovascular Autonomic Neuropathy, Type 2 Diabetes Mellitus, Diabetic Neuropathies
- Being tested
- Acupuncture, Mecobalamin
- Keywords
- Acupuncture; Xinshu (BL15); Jueyinshu (BL14); Yishu (EX-B3); Mecobalamin; Heart Rate Variability
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
MecobalaminDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Plus Mecobalamin | Experimental | 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. Receives: Procedure: Acupuncture; Drug: Mecobalamin |
| Mecobalamin Alone | Active comparator | Standard glucose-lowering treatment plus oral mecobalamin 0.5 mg three times daily for 6 weeks, without acupuncture. Receives: Drug: Mecobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 May 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Cardiovascular Autonomic NeuropathyStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to an acupuncture group (acupuncture plus mecobalamin) or a control group (mecobalamin alone). Both groups continue standard glucose-lowering treatment for 6 weeks.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907536
- Sponsor's protocol ID
- NDTHNanjingUMS 2026
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07907536
- Acronym / sponsor ID
- NDTHNanjingUMS 2026
- Conditions
- Diabetic Cardiovascular Autonomic Neuropathy, Type 2 Diabetes Mellitus, Diabetic Neuropathies
- Keywords
- Acupuncture; Xinshu (BL15); Jueyinshu (BL14); Yishu (EX-B3); Mecobalamin; Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to an acupuncture group (acupuncture plus mecobalamin) or a control group (mecobalamin alone). Both groups continue standard glucose-lowering treatment for 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Plus Mecobalamin | Experimental | Procedure: Acupuncture, Drug: MecobalaminStandard 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. |
| Mecobalamin Alone | Active comparator | Drug: MecobalaminStandard glucose-lowering treatment plus oral mecobalamin 0.5 mg three times daily for 6 weeks, without acupuncture. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureManual 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. | Procedure or surgery | Acupuncture Plus Mecobalamin |
| MecobalaminOral 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. | Drug | Acupuncture Plus Mecobalamin, Mecobalamin Alone |
Primary outcome
Total Clinical Effective Rate Based on TCM Syndrome Score
Time frame: Baseline and week 6
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Mecobalamin in people with Diabetic Cardiovascular Autonomic Neuropathy and Type 2 Diabetes Mellitus, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Clinical Effective Rate Based on TCM Syndrome Score (time frame: Baseline and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.