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Study on Traditional Chinese Medicine Syndromes, Clinical Characteristics, and Multi-Omics Features in Patients with Type 2 Diabetes and Small Fiber Neuropathy

Clinical Characteristics of Small Fiber Neuropathy in Type 2 Diabetes Patients and Clinical Study on the Efficacy of Tangshen Formula Intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001535
Enrollment
Unknown
Registered
2026-06-20
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Diabetic peripheral neuropathy

Interventions

Diabetes Non-Neuropathic Lesion Group:no
Diabetes Small Fiber Neuropathy Group:no
Diabetic Large Fiber Neuropathy Group:None
Diabetes mellitus mixed neuropathy group:none

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for type 2 diabetes; (2) Age 18–75 years; (3) Blood glucose has been stable in the past 3 months, with HbA1c less than 9.0%; (4) Able to cooperate with examinations and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who have had diabetic ketoacidosis, ketosis, or severe hypoglycemia within the past 3 months; (2) Those with serious underlying diseases such as pernicious anemia, tumors, infections, or those with severe liver and kidney dysfunction, cardiovascular diseases, or a history of stroke; or those with mental illness, psychological disorders, or abnormal behavior; (3) Pregnant or breastfeeding women;

Design outcomes

Primary

MeasureTime frame
Neurological Examination;

Secondary

MeasureTime frame
General Information Collection;Clinical Phenotype Collection;Traditional Chinese Medicine (TCM) Symptom Collection;

Countries

China

Contacts

Public ContactHao Lu

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

luhao403@163.com13916719260

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026