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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
428
two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks
two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Change in Modified Japanese Orthopaedic Association (mJOA) score
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.
Time frame: 42±2 days
Change in mJOA score
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
Time frame: 14±2 days, 28±2 days, 56±2 days
Change in sensation of mJOA score
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Changes in pain or stiffness score for neck and shoulder
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in chest tightness score
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Changes in hand and arm numbness scores
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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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in numbness (or pain) scores from the chest to the toes
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in Motor dysfunction of the upper extremities of mJOA score
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Proportion of participants with at least 1 grade decline in Nurick grades
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in Traditional Chinese medicine (TCM) syndrome integrality
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Change in TCM syndrome score
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
Time frame: 14±2 days, 28±2 days, 42±2 days or 56±2 days