Xiaoke Tongbi decoction improves neurological function in patients with diabetic peripheral neuropathy: A double-blind randomized controlled trial

Xiaoke Tongbi decoction improves neurological function in patients with diabetic peripheral neuropathy: a double-blind randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075742

Enrollment

Unknown

Registered

2023-09-14

Start date

2023-09-15

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Diabetic peripheral neuropathy

Interventions

control group:Mecobalamin tablets + placebo granules 2 bags, twice a day

treatment group:Mecobalamin tablets + Xiaoke Tongbi Decoction granules 2 bags, twice a day

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) patients who met the above western medical diagnostic criteria for diabetic peripheral neuropathy; (2) Age of 18-75 years old, male or female; (3) symptoms such as numbness of DPN; (4) Electromyography showed abnormal conduction velocity of at least two nerves (at least one nerve in the lower extremity); (5) Toronto clinical score =7; (6) Informed consent and signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) neuropathy caused by other diseases, such as cervical and lumbar diseases (nerve root compression, spinal stenosis, cervical and lumbar degeneration), cerebral infarction, Guillain-Barre syndrome, severe arteriovenous vascular diseases (venous embolism, lymphangitis), etc., neurotoxicity caused by drugs, especially chemotherapy drugs and metabolic poisons caused by renal insufficiency; (2) severe cardiac, hepatic and renal dysfunction (creatinine clearance < 60ml/min, alanine aminotransferase =2.5 times upper limit of normal, total bilirubin =1.5 times upper limit of normal; Chronic heart failure, cardiac function grade III and above). (3) malignant tumors; (4) patients with mental illness; (5) pregnant or lactating women; (6) acute complications of diabetes or concurrent infection within the past 1 month, or glycosylated hemoglobin =11%; (7) patients with allergic constitution or previous history of drug allergy in this study.

Design outcomes

Primary

Measure	Time frame
Changes in nerve electrophysiological conduction velocity;Vibration perception threshold;	—

Secondary

Measure	Time frame
Toronto Clinical Score;Patient global impression change score;TCM symptom rating scale;	—

Countries

China

Contacts

Public ContactZhenjie Liu

Fangcun Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine

zhenjl@139.com+86 137 1175 8166

Outcome results

None listed

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