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The clinical trial of Neurotropin to repair spinal cord injury: a randomized controlled trial

The clinical trial of Neurotropin to repair spinal cord injury: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039305
Enrollment
Unknown
Registered
2020-10-22
Start date
2020-11-30
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Spinal Cord Injury

Interventions

Intervention group:Basic treatment + Symptomatic treatment + Laminectomy + Neurotropin
Control group:Basic treatment + Symptomatic treatment + Laminectomy + Normal saline

Sponsors

Shandong University Qilu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-65 years; 2. Subjects with complete behavioral ability who are willing and able to participate in the follow-up study; 2. Patients with complete spinal cord injury: Asia A-B injury; 3. Patients within 48 hours after injury; 4. Patients with other lesions were excluded by MRI scan in the injured area; 5. Subjects without other compound injuries.

Exclusion criteria

Exclusion criteria: 1. Patients with severe opportunistic infection or opportunistic tumor; 2. Patients with abnormal blood routine examination (leucocyte < 3 x 10^9 /L, hemoglobin < 90g/L, neutrophil < 1.5 x 10^9/L, platelet < 75 x 10^9 /L); 3. Patients with definite liver disease (HBsAg / HCV antibody positive), or abnormal liver function (ALT and / or ast more than 3 times of the upper limit of the normal value, or total bilirubin more than 2 times of the upper limit of the normal value); 4. Patients with renal insufficiency (glomerular filtration rate < 70ml / min or creatinine above the upper limit of normal value); 5. Patients with severe chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases, active bleeding, severe hypertension, severe thrombocytopenia and hyperkalemia; 6. Patients with previous pancreatitis; 7. Pregnant and lactating women; 8. Patients with allergic constitution or known allergy to the ingredients of the drug and the background drugs specified in the protocol; 9. Suspected or confirmed patients with history of alcohol and drug abuse; 10. Those who participated in clinical trials of other drugs (except traditional Chinese Medicine) within three months before screening; 11. Other factors considered unsuitable for the trial by the researchers.

Design outcomes

Primary

MeasureTime frame
ASIA spinal cord injury score ;Neuroelectrophysiological examination ;MRI;Cerebrospinal fluid test;

Secondary

MeasureTime frame
Routine examination;Imaging and ultrasonography examination;

Countries

China

Contacts

Public ContactShiqing Feng

Shandong University Qilu Hospital

sqfeng@tmu.edu.cn+86 13920286292

Outcome results

None listed

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