The efficiency and safety of oral lipoic acid for the treatment of diabetic small neuropathy and diabetic corneal neuropathy: a double-blind, randomised, controlled, multicenter clinic trail

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025489

Enrollment

Unknown

Registered

2019-08-28

Start date

2019-11-30

Completion date

Unknown

Last updated

2019-09-02

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

Conditions

diabetic small neuropathy and diabetic corneal neuropathy

Interventions

experimental group:Lipoic acid + methylcobalt amine treatment

control group:placebo+ methylcobalt amine treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with type 2 diabetes; 2. Aged 18 to 75 years, male or female; 3. FBG =6 ?MNSI total symptom scores > 5?, MNSI total sign scores >3?,SFN-SIQ score>=6?; 6. No drugs prescribed to treat sensory abnormalities within two months; 7. Voluntary to attend this study signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to experimental medicine. 2. BMI 35Kg/m2. 3. SBP > 190mmHg or DBP >100 mmHg. 4. Heart dysfunction (NYHA >= 3 grade) or kidney dysfunction (eGFR=2.5 fold of narmal). 5. Pregnancy test shows positive, lactating women, those who disagree with effective contraceptive measures during the study period. 6. Drugs banned by the study in use (such as epalrestat , heparinWarfarinTCA and so on) 7. History of malignant neoplasms or tuberculosis. 8. Participation in another drug trial within 4 weeks. 9. Peripheral vascular occlusion disease (ABI>0.99), or Severe lumbar disease (combined with spinal cord compression) 10. Guillain-Barre syndrome, dermatomyositis and other nervous system diseases. 11. Physically disabled or mentally disabled, unable to understand experiments or unable to collaborate Subgroup study. 12.History of wearing contact lenses; history of eye infections, surgery or trauma. 13.Acute complications of diabetes(e.g. diabetic ketoacidosis hypertonic state). 14.Severe systemic diseases, such as heart and lung dysfunction, etc.. 15.Allergy to Obkaine hydrochloride eye dropsd.

Design outcomes

Primary

Measure	Time frame
TSS score;MNSI score;SFN-SIQ score;	—

Secondary

Measure	Time frame
VAS score;SAS, SDS;Sleep quality score;Oxidative stress indicators;urinary albumin to creatinine ratio;	—

Countries

China

Contacts

Public ContactFang Liu

Shanghai Sixth People's Hospital

liufangstar@163.com+86 18930177033

Outcome results

None listed

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