Cervical spondylotic myelopathy
Conditions
Interventions
Treatment group:Oral Jinbi Fang granules, 2 bags/time, 3 times/day, morning, middle and evening oral treatment for 8 weeks
Control group:Oral Jinbi Fang granules simulated placebo, 2 bags/time, 3 times/day, morning, middle and evening oral treatment for 8 weeks
Sponsors
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed according to the diagnostic principles for cervical spondylotic myelopathy specified in the "Expert Consensus on Classification, Diagnosis, and Nonsurgical Treatment of Cervical Spondylosis" (2018), with confirmed cases meeting the diagnostic criteria; 2. Patients with mild to moderate condition (mJOA score >=12 points); 3. TCM pattern identification classified as "Bi syndrome type"; 4. Willing to accept traditional Chinese medicine treatment; 5. Aged between 18 and 75 years (>=18 and <=75 years); 6. No other treatments received within 2 weeks prior to screening; 7. Voluntarily agreed to participate in the trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with obvious concurrent syndromes or complications (e.g., systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg while on antihypertensive medication; fasting blood glucose >= 7.0 mmol/L while on antidiabetic therapy); 2. Women who are breastfeeding, pregnant, or planning to become pregnant; 3. Patients with other types of cervical spondylosis (such as radiculopathy-type or vertebral artery-type cervical spondylosis); 4. Sagittal diameter of the spinal canal = 3.5 mm anteriorly or posteriorly, or intervertebral angulation >= 11°); 5. MRI showing T2-weighted hyperintensity indicating spinal cord degeneration, or spinal canal stenosis reaching 1/2, or spinal cord compression involving >= 3 segments; 6. Physical examination revealing positive dynamic Hoffman’s sign, hand muscle atrophy, spasticity, difficulty walking independently, or urinary dysfunction; 7. Patients with cervical spine fracture, congenital cervical deformity, bony cervical spinal stenosis, ossification of the posterior longitudinal ligament, or multiple sclerosis; 8. Postoperative patients with cervical spondylotic myelopathy; 9. Individuals with a history of multiple drug allergies or known allergic constitution; 10. Patients with severe primary diseases involving the liver, kidney, hematopoietic system, endocrine system, malignancies, or psychiatric disorders; 11. Individuals who have participated in or are currently participating in other drug clinical trials within 3 months prior to enrollment; 12. Presence of any other condition deemed by the investigator as unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Revised Japanese Orthopaedic Association Score (mJOA Score);Chinese Medicine Disease Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in clinical symptoms signs and points of spinal cervical spondylosis;Quality of life (using SF-36 scale) scores;Nurick score; | — |
Countries
China
Contacts
Public ContactCui Xuejun
Institute of Spinal Diseases, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed