Cervical spondylotic radiculopathy
Conditions
Interventions
Experimental Group:Jing Su Ke Li, 1 bag a time, TID, treated for 4 weeks
Control Group:Placebo
Sponsors
Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with cervical spondylotic radiculopathy; 2. 4 = VAS = 6; 3. Aged between 18 and 65 years old; 4. Agreed to participate in study and provided informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patient diagnosed with cervical spondylotic myelopathy; 2. Pain caused by cervical extraspinal lesions, such as thoracic outlet syndrome, tennis elbow, carpal tunnel syndrome, cubital tunnel syndrome, frozen shoulder, biceps tendinitis etc.; 3. Patients who needed surgery to treat cervical spondylotic radiculopathy, defined as i. ineffective symptom management or effective but frequently recurrent symptoms severely affect normal life and work after standard and systematic non-surgical therapies for more than 3-6 months; ii progressive muscle atrophy due to cervical root lesions; iii. Significant symptoms of cervical root irritation, acute severe pain seriously affect sleep and normal life. 4. Patients with serious primary disease of cardiovascular system, cerebrovascular system, liver, kidney and hematopoietic system; 5. Abnormal liver & kidney function ( AST, AST > 3 ULN or Creatinine > ULN); 6. History of mental illness, alcohol or drug abuse; 7. Known allergy to multiple drugs, or any ingredient of study drug; 8. Pregnant, ready-to-be pregnant(except for termination of pregnancy) or lactating women; 9. Patient who used any other drug intended to treat cervical spondylotic radiculopathy one week before study drug administration; 10. Patients who participated in other drug clinical study three months before screening; 11. Patients who are inappropriate to participate in the study for other reasons judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in pain VAS score (overall pain, shoulder pain, neck pain, shoulder pain) compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| the change in the Neck Disability Index (NDI) score compared to baseline;the change in the numbness VAS score compared to baseline;The rate of pain disappearance ;The rate of numbness disappearance ;SF-36 Health Questionnaire;Time to pain disappearance;Time to numbness disappearance;Rate of early withdrawal due to lack of efficacy;Adverse Events; | — |
Countries
China
Contacts
Public ContactQiu Xinggui
Outcome results
None listed