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

NCT06377072 | Completed Phase 3

• 1 other identifier: SHPL-W036-301
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylotic Myelopathy

Keywords

Qi deficiency; Blood stasis; Kidney deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change in mJOA score

  14±2 days, 28±2 days, 56±2 days

• Change in sensation of mJOA score

  14±2 days, 28±2 days, 42±2 days or 56±2 days

• Changes in pain or stiffness score for neck and shoulder

  14±2 days, 28±2 days, 42±2 days or 56±2 days

• Change in chest tightness score

  14±2 days, 28±2 days, 42±2 days or 56±2 days

• Changes in hand and arm numbness scores

  14±2 days, 28±2 days, 42±2 days or 56±2 days

Other Outcomes (19)

• Serious adverse events

  14±2 days，28±2 days，42±2 days or 56±2 days

• Adverse events

  14±2 days，28±2 days，42±2 days or 56±2 days

• Vital sign (systolic and diastolic blood pressure after 10-minute rest)

  14 days before administration, 14±2 days，28±2 days，42±2 days or 56±2 days

Study Arms (2)

Shenqi Sherong Pill

EXPERIMENTAL

6g per bag

Drug: Shenqi Sherong Pill

Placebo

PLACEBO COMPARATOR

6g per bag

Drug: Placebo

Interventions

Placebo DRUG

two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks

Placebo

Shenqi Sherong Pill DRUG

two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks

Shenqi Sherong Pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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);
• 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;
• Woman in lactation, pregnancy, or planned pregnancy;
• Participant is allergic constitution or known to be allergic to the components of the investigational drug;
• Participants have participated or are participating in other clinical trials within 3 months;
• 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.

Sponsors & Collaborators

• Shanghai Hutchison Pharmaceuticals Limited: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

Study Officials

• Bolai Chen, doctor

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 22, 2024
• Study Start: May 11, 2024
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)