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Evidence-based evaluation research on the treatment of diabetic peripheral neuropathy with the method of traditional Chinese medicine (Yiqi Wenjing Huoxue Tongluo)-A practical RCT study based on Zelen's design

Evidence-based evaluation research on the treatment of diabetic peripheral neuropathy with the method of traditional Chinese medicine (Yiqi Wenjing Huoxue Tongluo)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001003
Enrollment
Unknown
Registered
2026-04-16
Start date
2025-08-21
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Diabetic peripheral neuropathy

Interventions

treatment group:On the basis of basic treatment, the Tangbi formula is added
control group:Etiological treatment: Control blood sugar and glycated hemoglobin levels to maintain stable blood sugar including measures such as adjusting diet exercising and taking hypoglycemic drug

Sponsors

China-japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for type 2 diabetic peripheral neuropathy (DPN) 2.It conforms to the diagnostic criteria for Yang deficiency and cold coagulation syndrome in traditional Chinese medicine 3.Age >=30 and <=70 years old 4.At least one major symptom of diabetic peripheral neuropathy (numbness, pain, or abnormal sensation) is present. 5.Electromyography examination shows that at least two nerves have decreased conduction velocity. 6.Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetic ketoacidosis, ketosis acidosis, and severe infections within the last month. 2. Patients with severe systemic diseases such as heart, brain, lung, liver, kidney, tumors, and hematological system diseases and their resulting neuropathies, as well as neuropathies caused by long-term alcohol consumption and other factors. 3. Patients with serum transaminase levels more than twice the upper limit of normal and serum creatinine levels more than 1.5 times the upper limit of normal. 4. Patients with mental illness. 5. Pregnant, women planning to become pregnant, or lactating women. 6. Patients with a history of multiple drug allergies or allergies to the components of this drug. 7. Patients who have participated in other clinical studies within the last month. 8. Patients who have taken traditional Chinese medicines or Chinese patent medicines with similar components to the ingredients of Tangbi Formula within the last month.

Design outcomes

Primary

MeasureTime frame
The rate of disappearance of symptoms of diabetic peripheral neuropathy;

Secondary

MeasureTime frame
Visual analogue scale VAS;Traditional Chinese Medicine (TCM) Syndrome Score;Toronto Neuropathy score TCSS;Michigan diabetic peripheral Neuropathy Score MNSI;Electromyography;

Countries

China

Contacts

Public ContactPeng Dantao

China-japan Friendship Hospital

pengdantao2000@163.com13910908579

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026