Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy

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 andkidney 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 andflexion lateral and double oblique) indicates cervical degenerative changes, whileMRI examination indicates spinal cord compression;

6. The first diagnosis of Cervical Spondylotic Myelopathy within 3 months; for thosediagnosed for more than 3 months, the investigator needs to determine that thecondition is basically stable;

7. Participants voluntarily participate in this experiment and sign an informedconsent.

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 lastdrug use is less than 7 half-lives, or Traditional Chinese Medicine, drugs with nomarked half-life, physical therapy, etc. is less than 3 days before screening forthe treatment of this disease;

2. Participants with obvious concurrent syndrome or complication (such as Hypertensionafter taking antihypertensive drugs who systolic pressure ≥160mmHg, or diastolicpressure ≥100mmHg , or Diabetes after taking antidiabetic drugs who fasting bloodglucose ≥10.0mmol/L and so on);

3. MRI examination shows the degree of spinal stenosis is 1/2 or more, or the spinalcord compression caused by cervical spondylosis is three or more segments;

4. Participants with severe hand muscle atrophy, or spasms, or is difficult to walkindependently, or urinary dysfunction;

5. Participants with cervical spine fracture, or congenital deformity of cervicalspine, or ossification of ligamentum flavum, or ossification of posteriorlongitudinal ligament, or with neurological diseases such as lateral sclerosis andmultiple sclerosis;

6. Participants with visual analogue scale(VAS) score >7 points (7 points is defined asthe distance between the left end and the mark location equal to 7.0cm);

7. Participants with severe heart disease, such as myocardial infarction, unstableangina pectoris, Ⅲ to Ⅳ congestive heart failure and severe arrhythmia according toNew York Heart Association (NYHA),or with severe liver and kidney diseases, or withabnormal liver and kidney function tests (Alanine aminotransferase or Aspartateaminotransferase ≥ 1.5 times the upper limit of normal, or creatinine clearance> theupper 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 ofthe 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 thestudy.

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.