Cervical Spondylotic Myelopathy
Conditions
Keywords
Qi deficiency, Blood stasis, Kidney deficiency
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration.
Detailed description
1. Trial Design： This is a multi-center, randomized, double-blind, placebo-controlled phase III study，which plans to enroll 428 participants who will be randomized to Shenqi Sherong pill group or placebo control group. The Modified Japanese Orthopaedic Association (mJOA) Score combined with the changes of clinical symptoms and syndrome score are used as the validity index. The laboratory examination and incidence of adverse events are used as the safety index. 2. Therapeutic schedule： Participants will be provided with neck braces and recommended to wear them daily or outdoors along with health education. Participants will be treated with the investigational drug (Shenqi Sherong Pill or placebo ) by taking two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks, with a 2-week follow-up after withdrawal.
Interventions
DRUGShenqi Sherong Pill
two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks
DRUGPlacebo
two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks
Sponsors
Shanghai Hutchison Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. Note: 1) CT examination is determined by the investigator according to the specific conditions of participants. 2) Imaging materials of MRI, X-ray(frontal, lateral, hyperextension and flexion and double oblique), CT examination within 3 months from the 3A Grade hospital can be accepted ; 3) If the laboratory tests and 12-lead electrocardiogram are completed in the research center on the same day before the participant signing an informed consent, the examination can not be repeated after the investigator judging.
Exclusion criteria
Participants should be excluded if they meet any one
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Japanese Orthopaedic Association (mJOA) score | 42±2 days | Change in Modified Japanese Orthopaedic Association (mJOA) score (on a scale from 0 to 18, with lower scores indicating greater disability) from baseline at Day 42 after administration; the mJOA which is a clinician administered scale to evaluate four clinical dimensions; motor dysfunction score for upper and lower extremities, sensation loss and sphincter dysfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mJOA score | 14±2 days, 28±2 days, 56±2 days | Changes in mJOA score (on a scale from 0 to 18, with lower scores indicating greater disability) from baseline at Day 14，Day 28 and Day 56 after administration |
| Change in sensation of mJOA score | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Changes in sensation of mJOA score (on a scale from 0 to 3, with lower scores indicating greater disability) from baseline at Day 14, Day 28, Day 42 and Day 56 after administration |
| Changes in pain or stiffness score for neck and shoulder | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Changes in pain or stiffness score (on a scale from 0 to10, with higher scores indicating greater pain) for neck and shoulder from baseline at Day 14, Day 28, Day 42 and Day 56 after administration |
| Change in chest tightness score | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Change in chest tightness score (on a scale from 0 to10, with higher scores indicating greater tightness) from baseline at Day 14, Day 28, Day 42 and Day 56 after administration |
| Changes in hand and arm numbness scores | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Changes in hand and arm numbness scores (on a scale from 0 to10, with higher scores indicating greater numbness) at Day 14, Day 28, Day 42 and Day 56 after administration |
| Change in numbness (or pain) scores from the chest to the toes | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Changes from baseline in numbness (or pain) scores (on a scale from 0 to10, with higher scores indicating greater numbness or pain) from the chest to the toes at Day 14, Day 28, Day 42 and Day 56 after administration |
| Change in Motor dysfunction of the upper extremities of mJOA score | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Change in Motor dysfunction of the upper extremities of mJOA score (on a scale from 0 to 5, with lower scores indicating greater disability) at Day 14, Day 28, Day 42 and Day 56 after administration |
| Proportion of participants with at least 1 grade decline in Nurick grades | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Proportion of participants with at least 1 grade decline from baseline in Nurick grades (on a scale from 0 to 5, with higher scores indicating greater disability) at Day 14, Day 28, Day 42 and Day 56 after administration |
| Change in Traditional Chinese medicine (TCM) syndrome integrality | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Change in Traditional Chinese medicine (TCM) syndrome integrality (on a scale from 0 to 9, with higher scores indicating greater seriousness) at Day 14, Day 28, Day 42 and Day 56 after administration |
| Change in TCM syndrome score | 14±2 days, 28±2 days, 42±2 days or 56±2 days | Change in TCM syndrome score (on a scale from 0 to 9, with higher scores indicating greater seriousness) at Day 14, Day 28, Day 42 and Day 56 after administration |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORBolai Chen, doctor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed