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A Study on the Improving Effect of Compound Danshen Dripping Pills on 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(DPN)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121877
Enrollment
Unknown
Registered
2026-04-07
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Diabetes Mellitus?Diabetic Peripheral Neuropathy?Limb Numbness?Limb Weakness?Pain

Interventions

Control group:Administer routine Western medicine treatment to the patient.
Treatment group:In the control group, mecobalamin tablets (Eisai (China) Pharmaceutical Co., Ltd.
National Medicine Standard H20143107) were administered at 0.5 mg three times a day, and beclopulsate sodium tablets (Chengdu Yuandong Biological Pharmaceutical Co., Ltd.
National Medicine Standard H20243696) at 40 µg per dose, three times a day. On this basis, Compound Danshen Dripping Pills (Tasly Pharmaceutical Group Co., Ltd.
National Medicine Standard Z10950111) were added, three times a day, 10 pills per dose.

Sponsors

Huai'an First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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.Confirmed diagnosis of diabetic peripheral neuropathy for 3 to 8 years. 3.Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Sensory Nerve Action Potential (SNAP) Amplitude of the Sural Nerve;

Countries

China

Contacts

Public ContactSun Chengmei

Huai'an First People's Hospital

scmstss@126.com+86 517 8087 2341

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026