Clinical trial NCT06377072: Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Shenqi Sherong Pill in Cervical Spondylotic Myelopathy (Qi Deficiency, Blood Stasis and Kidney Deficiency Type)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Spondylotic Myelopathy
Keywords: Qi deficiency
Blood stasis
Kidney deficiency
Lead sponsor: Shanghai Hutchison Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

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 :

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 (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;
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.

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.

Primary outcomes:
measure: Change in Modified Japanese Orthopaedic Association (mJOA) score
timeFrame: 42±2 days
Secondary outcomes:
measure: Change in mJOA score
timeFrame: 14±2 days, 28±2 days, 56±2 days
measure: Change in sensation of mJOA score
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Changes in pain or stiffness score for neck and shoulder
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Change in chest tightness score
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Changes in hand and arm numbness scores
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Change in numbness (or pain) scores from the chest to the toes
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Change in Motor dysfunction of the upper extremities of mJOA score
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Proportion of participants with at least 1 grade decline in Nurick grades
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Change in Traditional Chinese medicine (TCM) syndrome integrality
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Change in TCM syndrome score
timeFrame: 14±2 days, 28±2 days, 42±2 days or 56±2 days
Other outcomes:
measure: Serious adverse events
timeFrame: 14±2 days，28±2 days，42±2 days or 56±2 days
measure: Adverse events
timeFrame: 14±2 days，28±2 days，42±2 days or 56±2 days
measure: Vital sign (systolic and diastolic blood pressure after 10-minute rest)
timeFrame: 14 days before administration, 14±2 days，28±2 days，42±2 days or 56±2 days
measure: Vital sign (body temperature)
timeFrame: 14 days before administration, 14±2 days，28±2 days，42±2 days or 56±2 days
measure: Vital sign (respiration)
timeFrame: 14 days before administration, 14±2 days，28±2 days，42±2 days or 56±2 days
measure: Vital sign (heart rate）
timeFrame: 14 days before administration, 14±2 days，28±2 days，42±2 days or 56±2 days
measure: Laboratory test indicator (blood routine)
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: Laboratory test indicator (liver function)
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: Laboratory test indicator (kidney function)
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: Laboratory test indicator (fasting glucose)
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: Laboratory test indicator (urine routine and urinary sediment count)
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: Laboratory test indicator (stool routine and occult blood)
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: Electrocardiogram(ECG) QT Interval
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: ECG QTc Interval
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: ECG QRS Interval
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: ECG PR Interval
timeFrame: 14 days before administration, 14±2 days or 42±2 days
measure: Pathological sign (Hoffmann sign)
timeFrame: 14 days before administration, 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Pathological sign (Babinski sign)
timeFrame: 14 days before administration, 14±2 days, 28±2 days, 42±2 days or 56±2 days
measure: Concomitant medication
timeFrame: 14 days before administration, 14±2 days, 28±2 days, 42±2 days or 56±2 days
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Bolai Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: