A Multicenter, randomized, double-blind, positive controlled clinical study to assess the efficacy and safety of Acetyl L-Carnitine in the treatment of diabetic peripheral neuropathy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-08000141

Enrollment

Unknown

Registered

2008-08-23

Start date

2008-07-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Diabetic peripheral neuropathy

Interventions

Test Group:Acetyl L-Carnitine ,0.5g tid,PO after dinner

Control group:Mecobalamin Tablets 0.5mg tid,PO after dinner.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Understanding and willing to participate in this clinical trial and to provide signed informed consent; 2. Aged 18-70 years,gender is not limited; 3. Definition of Diabetes: according to WHO recommendation (1999); 4. Suffering from diabetic peripheral neuropathy, and the upper or lower limb with a nerve conduction velocity (MNCV, SNCV), or nerve conduction amplitude (CMAP, SNAP) in patients with abnormal; 5. Urine or blood of women of childbearing age pregnancy test negative.

Exclusion criteria

Exclusion criteria: 1. Into the group two weeks ago,patients with poor blood sugar control:HbA1c>8.5%; 2. Peripheral neuropathy was caused by Non-diabetic disease such as brain tumors, trauma, Neural factors; 3. Allergic or intolerance toAcetyl L-Carnitine; 4. Patients with abnormal thyroid function, or have a history of thyroid disease, or are receiving treatment; 5. Patients with severe bleeding disorders; 6. Patients with Peptic ulcer; 7. Patients with severe hypertension, unstable angina pectoris, severe arrhythmia, cardiac insufficency a, pulmonary incompetence, a myocardial infarction history within six months before entered into the group or planting a pacemaker, stent; 8. Liver or kidney dysfunctioor: ALT and / or AST two times more than laboratory indicators normal ceiling; Cr over the laboratory indicators normal ceiling; 9. Patients with any malignant tumor including intracranial tumor; 10. suckling women, pregnant women, Women of childbearing age or partners do not agree with male patients in the study to take effective contraceptive measures; 11. Patients with alcohol addiction and drug abuse one year before entering into the group; 12. Patients with poor compliance; 13. Patients participate in other clinical trials at the same time or within three months before entering into the group; 14. Other patients the researchers deemed were not suitable for the thial.

Design outcomes

Primary

Measure	Time frame
changes in NSS / NDS score;	—

Secondary

Measure	Time frame
Changes in nerve conduction velocity;changes in NSS / NDS score;	—

Countries

China

Contacts

Public ContactHaoming Tian

hmtian999@yahoo.com.cn+86 28 81812303

Outcome results

None listed

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