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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shenqi Sherong Pill | Experimental | 6g per bag |
|
| Placebo | Placebo Comparator | 6g per bag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenqi Sherong Pill | Drug | two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 42±2 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14±2 days, 28±2 days, 56±2 days |
| Change in sensation of mJOA score |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | The number and incidence of serious adverse events at Day 14, Day 28, Day 42 and Day 56 after administration | 14±2 days,28±2 days,42±2 days or 56±2 days |
| Adverse events | The number and incidence of adverse events at Day 14, Day 28, Day 42 and Day 56 after administration |
Inclusion Criteria:
Participants can only be selected if they meet all the inclusion criteria
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 exclusion criteria :
Note: 1) If examination or efficacy index score of visit 1 and visit 2 is overlapping item, the baseline standard is based on visit 2; 2) Participant who has the abnormal laboratory examination items during screening can be arranged for retest, whether to be enrolled or not will be comprehensively evaluated by the investigators.
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| Name | Affiliation | Role |
|---|---|---|
| Bolai Chen, doctor | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510000 | China |
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| Placebo | Drug | two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks |
|
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
| 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 | 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 | 14±2 days, 28±2 days, 42±2 days or 56±2 days |
| Changes in hand and arm numbness scores | 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 | 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 | 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 | 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 | 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 | 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 | 14±2 days, 28±2 days, 42±2 days or 56±2 days |
| 14±2 days,28±2 days,42±2 days or 56±2 days |
| Vital sign (systolic and diastolic blood pressure after 10-minute rest) | Number of participants with abnormal blood pressure, assessed by systolic and diastolic blood pressure before and after administration | 14 days before administration, 14±2 days,28±2 days,42±2 days or 56±2 days |
| Vital sign (body temperature) | Change in body temperature from baseline or screening period at Day 14, Day 28, Day 42 and Day 56 after administration | 14 days before administration, 14±2 days,28±2 days,42±2 days or 56±2 days |
| Vital sign (respiration) | Change in respiration from baseline or screening period at Day 14, Day 28, Day 42 and Day 56 after administration | 14 days before administration, 14±2 days,28±2 days,42±2 days or 56±2 days |
| Vital sign (heart rate) | Change in heart rate from baseline or screening period at Day 14, Day 28, Day 42 and Day 56 after administration | 14 days before administration, 14±2 days,28±2 days,42±2 days or 56±2 days |
| Laboratory test indicator (blood routine) | Number of participants with abnormal laboratory tests results, assessed by white blood cell, red blood cell, hemoglobin and platelet before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| Laboratory test indicator (liver function) | Number of participants with abnormal liver function, assessed by alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase and gamma-glutamyl transpeptidase before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| Laboratory test indicator (kidney function) | Number of participants with abnormal kidney function, assessed by serum creatinine, urinary microalbumin, urinary albumin to creatinine ratio, urinary N-Acetyl-β-D-glucosaminidase and urinary creatinine before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| Laboratory test indicator (fasting glucose) | Change in fasting glucose before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| Laboratory test indicator (urine routine and urinary sediment count) | Number of participants with abnormal urine analysis, assessed by urinary white blood cell, urinary red blood cell, urinary protein and urinary proportion before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| Laboratory test indicator (stool routine and occult blood) | Number of participants with abnormal stool analysis, assessed by stool routine and occult blood before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| Electrocardiogram(ECG) QT Interval | Change in ECG QT Interval before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| ECG QTc Interval | Change in ECG QTc Interval before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| ECG QRS Interval | Change in ECG QRS Interval and PR Interval before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| ECG PR Interval | Change in ECG PR Interval before and after administration | 14 days before administration, 14±2 days or 42±2 days |
| Pathological sign (Hoffmann sign) | Changes of Hoffmann sign from baseline or screening period at Day 14, Day 28, Day 42 and Day 56 after administration | 14 days before administration, 14±2 days, 28±2 days, 42±2 days or 56±2 days |
| Pathological sign (Babinski sign) | Changes of Babinski sign from baseline or screening period at Day 14, Day 28, Day 42 and Day 56 after administration | 14 days before administration, 14±2 days, 28±2 days, 42±2 days or 56±2 days |
| Concomitant medication | Number of participants with concomitant medication throughout the study period | 14 days before administration, 14±2 days, 28±2 days, 42±2 days or 56±2 days |