cervical spondylotic myelopathy
Conditions
Interventions
Jingbi Formula Group:Jingbi Formula Granules Oral Administration Twice a Day
Placebo control group:Oral administration of placebo granules twice a day
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Those who meet the diagnostic criteria for cervical spondylotic myelopathy; (2) Mild and moderate patients (mJOA score = 12); (3) Traditional Chinese medicine syndrome differentiation belongs to the "spasmodic syndrome type"; (4) Voluntary recipients of traditional Chinese medicine treatment; (5) Individuals aged = 18 years and = 75 years old; (6) Individuals who did not receive any other treatment within the first two weeks of screening; (7) Those who agree to participate in the experiment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with obvious mixed syndrome or complications (such as patients with hypertension systolic pressure = 160mmHg, diastolic pressure = 100mmHg, and diabetes fasting blood glucose = 7.0mmol/L after taking antidiabetic drugs); (2) Women who are breastfeeding, pregnant, or preparing for pregnancy; (3) Patients with other types of cervical spondylosis, such as nerve root type cervical spondylosis and vertebral artery type cervical spondylosis; (4) If the sagittal diameter of the spinal canal is less than 11mm and the Pavlvo ratio is less than 0.75 (the ratio of the sagittal diameter of the cervical canal to the sagittal diameter of the cervical body), or if there is vertebral instability (the forward or backward sliding distance of the vertebral body is greater than or equal to 3.5mm or the angle between the vertebral bodies is greater than or equal to 11 °); (5) MRI examination shows T2 weighted high signal, indicating spinal cord degeneration, or MRI examination shows spinal canal stenosis reaching 1/2, or spinal cord compression reaching three segments; (6) Physical examination shows positive dynamic Hoffman sign, or hand muscle atrophy, spasms, difficulty walking independently, or urinary dysfunction; (7) Accompanied by cervical spine fractures, congenital malformations of the cervical spine, cervical spinal stenosis, ossification of the posterior longitudinal ligament, and multiple sclerosis; (8) Postoperative patients with cervical spondylotic myelopathy; (9) Individuals with allergic constitution and allergies to multiple drugs; (10) Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system, tumors, and psychiatric disorders; (11) Individuals who participated in or are currently participating in clinical trials of other drugs within the first three months of being selected; (12) There are reasons why other researchers believe it is not suitable to be included in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mJOA score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nurick score;36-Item Short Form Survey Instrument; | — |
Countries
The People's Republic of China
Contacts
Public ContactXuejun Cui
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed