Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy (NCT06377072) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy
China428 participantsStarted 2024-05-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years old (including 18 and 75 years old), gender unlimited;
✓. Accord with Western medicine diagnosis standards of Cervical Spondylotic Myelopathy;
✓. Accord with Chinese medicine diagnosis standards of qi deficiency, blood stasis and kidney deficiency type;
✓. The disease classification was mild or moderate (13 ≤mJOA score ≤15);
✓. 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;
✓. 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;
✓. Participants voluntarily participate in this experiment and sign an informed consent.
Exclusion criteria
✕. 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;
✕. 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);
What they're measuring
1
Change in Modified Japanese Orthopaedic Association (mJOA) score
. 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;
✕. Participants with severe hand muscle atrophy, or spasms, or is difficult to walk independently, or urinary dysfunction;
✕. 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;
✕. 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);
✕. 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 (Alanine aminotransferase or Aspartate aminotransferase ≥ 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, chronic obstructive pulmonary disease(COPD) and other acute episodes;
✕. Participants with cerebral infarction and serious mental disorders;