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Phase 4, single-center, randomized, parallel, open clinical trial on the clinical effects of alpha-liposan injection-oral phase therapy in patients with standard treatment refractory/non-reactive diabetic neuropathy.

Phase 4, single-center, randomized, parallel, open clinical trial on the clinical effects of alpha-liposan injection-oral phase therapy in patients with standard treatment refractory/non-reactive diabetic neuropathy.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0011176
Enrollment
60
Registered
2025-11-19
Start date
2025-11-18
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

None listed

Interventions

Drug : In the case of insufficient pain control of more than 4 points of VAS while taking diabetic neuropathy drugs, or adverse reactions related to the drug such as dizziness, headache, drowsiness, s

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. adults over 19 years of age 2. Those diagnosed with diabetes (recruitment regardless of type 1 and type 2 diabetes) 3. a person with diabetic neuropathy 4. Those who have experienced drug-related side effects when administering Pregabalin, TCA, and duloxetine 5. If the medication mentioned in No. 4 is not administered or side effects are not felt at the time of administration, a person with pain of at least 4 VAS points

Exclusion criteria

Exclusion criteria: 1. a pregnant woman 2. Those who are scheduled to undergo surgery and inpatient treatment within one month (excluding hospitalization for diabetes education) 3. A person who has undergone chemotherapy within the last three years or plans to receive it 4. Those who have a history of taking prednisolone more than 10 mg per day within the last 3 months or are taking it 5. Those who have uncontrolled thyroid dysfunction 6. a person undergoing renal replacement treatment, including dialysis 7. A person who has a liver disease of Child-pugh class C or higher 8. persons who have difficulty in independent living and self-management

Design outcomes

Primary

MeasureTime frame
total symptom score (TSS)

Secondary

MeasureTime frame
MNSI-Q, MNSI-PE;Visual Analog Scale;DN-4 pain questionnaire;Autonomic Nervous System Abnormal Score, ;SUDOSCAN

Countries

Korea, Republic of

Contacts

Public ContactYoung Seon Ko

Seoul National University Bundang Hospital

kyscc99@gmail.com+82-31-787-7078

Outcome results

None listed

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