Cervical Spondylotic Myelopathy
Conditions
Interventions
Experimental Group:two bags each time, three times a day at half an hour after breakfast, lunch and dinner
Control group:two bags each time, three times a day at half an hour after breakfast, lunch and dinner
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants can only be selected if they meet all the inclusion criteria: 1. Age 18-75 years old (including 18 and 75 years old), gender unlimited; 2. Accord with Western medicine diagnosis standards of Cervical Spondylotic Myelopathy; 3. Accord with Chinese medicine diagnosis standards of qi deficiency, blood stasis and kidney deficiency type; 4. The disease classification was mild or moderate (13 =mJOA score =15); 5. X-ray examination of six cervical vertebrae (frontal, lateral, hyperextension and flexion lateral and double oblique) indicates cervical degenerative changes, while MRI examination indicates spinal cord compression; 6. The first diagnosis of Cervical Spondylotic Myelopathy within 3 months; for those diagnosed for more than 3 months, the investigator needs to determine that the condition is basically stable; 7. Participants voluntarily participate in this experiment and sign an informed consent.
Exclusion criteria
Exclusion criteria: Participants should be excluded if they meet any one exclusion criteria : 1. The use of long-acting hormone drugs within 1 week before screening, or the last drug use is less than 7 half-lives, or Traditional Chinese Medicine, drugs with no marked half-life, physical therapy, etc. is less than 3 days before screening for the treatment of this disease; 2. Participants with obvious concurrent syndrome or complication (such as Hypertension after taking antihypertensive drugs who systolic pressure =160mmHg, or diastolic pressure =100mmHg , or Diabetes after taking antidiabetic drugs who fasting blood glucose =10.0mmol/L and so on); 3. MRI examination shows the degree of spinal stenosis is 1/2 or more, or the spinal cord compression caused by cervical spondylosis is three or more segments; 4. Participants with severe hand muscle atrophy, or spasms, or is difficult to walk independently, or urinary dysfunction; 5. Participants with cervical spine fracture, or congenital deformity of cervical spine, or ossification of ligamentum flavum, or ossification of posterior longitudinal ligament, or with neurological diseases such as lateral sclerosis and multiple sclerosis; 6. Participants with visual analogue scale(VAS) score >7 points (7 points is defined as the distance between the left end and the mark location equal to 7.0cm); 7. Participants with severe heart disease, such as myocardial infarction, unstable angina pectoris, III to IV congestive heart failure and severe arrhythmia according to New York Heart Association (NYHA),or with severe liver and kidney diseases, or with abnormal liver and kidney function tests (ALT or AST= 1.5 times the upper limit of normal, or creatinine clearance> the upper limit of normal); or with severe lung disease such as chronic bronchitis, asthma, COPD and other acute episodes; 8. Participants with cerebral infarction and serious mental disorders; 9. Woman in lactation, pregnancy, or planned pregnancy; 10. Participant is allergic constitution or known to be allergic to the components of the investigational drug; 11. Participants have participated or are participating in other clinical trials within 3 months; 12. Participants are judged unsuitable for participation by the investigators in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in revised Japanese Orthopedic Association (mJOA) score at Week 6 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in mJOA score at week 2, week 4 of treatment, and 2 weeks after withdrawal.;Changes from baseline in sensation of mJOA score at Week 2, Week 4, Week 6, and 2 weeks after withdrawal.;Changes from baseline in pain or stiffness score for neck and shoulder at Week 2, Week 4, Week 6 of treatment, and 2 weeks after withdrawal.;Changes from baseline in chest tightness score at Week 2, Week 4, Week 6 of treatment, and 2 weeks after withdrawal.;Changes from baseline in hand and arm numbness scores at Weeks 2, 4, and 6 of treatment and 2 weeks after withdrawal.;Changes from baseline in numbness (or pain) scores from the chest to the toes at Week 2, Week 4, Week 6, and 2 weeks after withdrawal.;Changes from baseline in Motor dysfunction of the upper extremities of mJOA score at weeks 2, 4, and 6 of treatment and 2 weeks after withdrawal.;Rates of at least 1 grade decline from baseline in Nurick grades at Week 2, Week 4, Week 6, and 2 weeks after withdrawal.;Changes from baseline in Traditional Chinese medicine (TCM) syndrome integrality at week 2, week 4, week 6 of treatment, and 2 weeks after withdrawal.;Changes from baseline in TCM syndrome score at week 2, week 4, week 6, and 2 weeks after withdral.;Safety Index: Adverse events (AE), vital signs (10-minute resting blood pressure, body temperature, respiration, heart rate), laboratory tests (blood routine, liver function, kidney function, fasting glucose, urine routine and urinary sediment count, stool routine and occult blood), 12-lead electrocardiogram (ECG), pathological signs, and combination medication; | — |
Countries
China
Contacts
Public ContactChen Bo Lai
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed