Randomized, double-blind, placebo-controlled, multicenter clinical trial of the efficacy and safety of Yunnan Hongyao Capsule in the treatment of diabetic distal symmetrical polyneuropathy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076675

Enrollment

Unknown

Registered

2023-10-16

Start date

2023-03-31

Completion date

Unknown

Last updated

2023-10-22

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

Conditions

Diabetic distal symmetrical polyneuropathy

Interventions

Control group:Mecobalamine tablets (Hinkun) + placebo

Experimental group:Mecobalamine tablets (Xinkun) + Yunnan Red Medicine capsules

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Consistent with the diagnosis of diabetic distal symmetrical polyneuropathy; (2) Age 18-80 years old, gender unlimited; (3) Voluntarily participate in this clinical trial, give informed consent and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) diabetic ketoacidosis and other severe cases; (2) seriously substandard blood glucose control (HBA1c > 10%); (3) Patients with severe primary diseases of cardiovascular and cerebrovascular systems, liver, kidney and hematopoietic systems (blood ALT and AST exceeded the upper limit of normal value 2.5 times; Blood creatinine more than 2 times the upper limit of normal; Systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg); (4) Patients with other neurological and vascular diseases or infected persons of lower limbs; (5) Women who are pregnant, lactating or planning to become pregnant; (6) Allergic to the experimental drug or allergic constitution; (7) Patients who have taken drugs with similar efficacy to the test drug (such as Huoxue Tongmai Tablet, Compound Xueshuantong Capsule, Yunnan Baiyao Capsule, etc.) in the past 2 weeks; (8) Patients who have participated in clinical trials of other drugs within the last 3 months; (9) Patients (such as patients with poor compliance) deemed unsuitable for clinical trials by the researchers. All the above criteria must not meet the screening to be included in the test

Design outcomes

Primary

Measure	Time frame
TCM symptom score;The Toronto Clinical Scoring System (TCSS) assesses neurological function;Nerve conduction velocity (NCV);Total clinical effective rate;	—

Countries

China

Contacts

Public ContactLi Jin

First Affiliated Hospital of Xiamen University

lijin@xmu.edu.cn+86 137 9984 9674

Outcome results

None listed

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