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Study on the Intervention Strategies and Translational Research of Traditional Chinese Medicine for Diabetic Neuropathy

Study on the Intervention Strategies and Translational Research of Traditional Chinese Medicine for Diabetic Neuropathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000411
Enrollment
Unknown
Registered
2025-02-25
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy

Interventions

Control Group:Methylcobalamin Tablets 0.5mg, three times a day, orally
Tangbi Group :Tangbi Granules 1 bag, three times a day, prepared by dissolving in water
Methylcobalamin and Tangbi Combination Group:Methylcobalamin Tablets 0.5mg, three times a day, orally plus Tangbi Granules 1 bag, three times a day, prepared by dissolving in water

Sponsors

Jiangsu province hospital of Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Those who meet the diagnostic criteria for type 2 diabetes combined with Diabetic Peripheral Neuropathy (DPN) in Western medicine and those who fit the syndrome criteria of Yin deficiency and blood stasis in Traditional Chinese Medicine; 2. Those with glycated hemoglobin (HbA1c) =9%; 3. Individuals aged between 30 and 75 years; 4. Those who provide informed consent and volunteer to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who have experienced severe diabetic ketoacidosis or infection within one month or those with severe diabetic foot gangrene; 2. Patients with proliferative diabetic retinopathy who have had photocoagulation events recently; 3. Patients with a history of malignant hypertension myocardial infarction cerebrovascular accidents or other critical conditions within one year and those with congestive heart failure grades I-IV who are currently using anticoagulant or antiplatelet medications; 4. Patients with cancer pregnancy or allergies to drugs in the treatment plan who are not suitable for this treatment regimen; 5. Patients with a history of severe primary heart liver lung kidney blood or severe diseases affecting their survival with blood ALT AST > 2N (N is the upper limit of normal) and Scr > 1.5N. 6. Neuropathies caused by other etiologies such as cervical and lumbar spine diseases (nerve root compression spinal stenosis degenerative changes of the cervical and lumbar spine) cerebral infarction Guillain-Barré syndrome excluding severe arteriovenous vascular diseases (venous thrombosis lymphangitis) and it is also necessary to differentiate the neurotoxic effects of drugs especially chemotherapeutic agents and the damage to nerves caused by metabolic toxins due to renal insufficiency.

Design outcomes

Primary

MeasureTime frame
Toronto Clinical Score (TCSS);

Secondary

MeasureTime frame
Neurophysiological Testing;Vitalscan;Ankle-Brachial Index;Sudoscan;Gastrointestinal Motility Study;Anxiety and Depression Score;

Countries

China

Contacts

Public ContactLijuan Wang

Jiangsu province hospital of Chinese medicine

23839508@qq.com+86 13815429808

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026