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A Randomized Controlled Study on the Improvement Effect of Compound Danshen Dripping Pills on Sural Nerve Action Potential Amplitude (SNAP) in Patients with Diabetic Peripheral Neuropathy

A Randomized Controlled Study on the Improvement Effect of Compound Danshen Dripping Pills on Sural Nerve Action Potential Amplitude (SNAP) in Patients with Diabetic Peripheral Neuropathy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000993
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-04-01
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:Diazepam 0.5 mg t.i.d., plus Beraprost sodium 40 µg t.i.d.
experimental group:Mecobalamin 0.5 mg t.i.d., beraprost sodium 40 µg t.i.d., Compound Danshen Dripping Pills 10 pills t.i.d.

Sponsors

Huai'an First People's Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: (1) Meet the diagnostic criteria of both Western medicine and Traditional Chinese Medicine (TCM), aged between 50 and 75 years, with a diabetes mellitus duration of 3 to 12 years. 2: (2) Confirmed diagnosis of diabetic peripheral neuropathy for 3 to 8 years. 3: (3) Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1:   (1) Presence of severe diabetes-related complications, such as severe heart failure, sequelae of stroke, etc. 2:   (2) Patients with a known allergy to the drugs used in the study. 3:   (3) Presence of peripheral neuropathy attributable to other causes (e.g., alcoholic neuropathy, or neuropathy due to immune disorders, malignancies, etc.). 4:   (4) Patients with psychiatric disorders that preclude cooperation with the treatment, as well as those with poor compliance. 5:   (5)Diabetic peripheral neuropathy in patients with intact sural nerve function 6:   (6)Type 1 diabetic patient

Design outcomes

Primary

MeasureTime frame
Amplitude of sural nerve sensory nerve action potential;

Secondary

MeasureTime frame
Traditional Chinese Medicine syndrome score;

Countries

China

Contacts

Public ContactSunchengmei

Huai'an First People's Hospital, Nanjing Medical University)

cmstss2026@163.com051780872341

Outcome results

None listed

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