protocolSection identificationModule nctId: NCT06377072, orgStudyIdInfo id: SHPL-W036-301, briefTitle: Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Shanghai Hutchison Pharmaceuticals Limited, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Cervical Spondylotic Myelopathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Shenqi Sherong Pill, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Modified Japanese Orthopaedic Association (mJOA) score, secondaryOutcomes measure: Change in mJOA score, secondaryOutcomes measure: Change in sensation of mJOA score, secondaryOutcomes measure: Changes in pain or stiffness score for neck and shoulder, secondaryOutcomes measure: Change in chest tightness score, secondaryOutcomes measure: Changes in hand and arm numbness scores, secondaryOutcomes measure: Change in numbness (or pain) scores from the chest to the toes, secondaryOutcomes measure: Change in Motor dysfunction of the upper extremities of mJOA score, secondaryOutcomes measure: Proportion of participants with at least 1 grade decline in Nurick grades, secondaryOutcomes measure: Change in Traditional Chinese medicine (TCM) syndrome integrality, secondaryOutcomes measure: Change in TCM syndrome score, otherOutcomes measure: Serious adverse events, otherOutcomes measure: Adverse events, otherOutcomes measure: Vital sign (systolic and diastolic blood pressure after 10-minute rest), otherOutcomes measure: Vital sign (body temperature), otherOutcomes measure: Vital sign (respiration), otherOutcomes measure: Vital sign (heart rate）, otherOutcomes measure: Laboratory test indicator (blood routine), otherOutcomes measure: Laboratory test indicator (liver function), otherOutcomes measure: Laboratory test indicator (kidney function), otherOutcomes measure: Laboratory test indicator (fasting glucose), otherOutcomes measure: Laboratory test indicator (urine routine and urinary sediment count), otherOutcomes measure: Laboratory test indicator (stool routine and occult blood), otherOutcomes measure: Electrocardiogram(ECG) QT Interval, otherOutcomes measure: ECG QTc Interval, otherOutcomes measure: ECG QRS Interval, otherOutcomes measure: ECG PR Interval, otherOutcomes measure: Pathological sign (Hoffmann sign), otherOutcomes measure: Pathological sign (Babinski sign), otherOutcomes measure: Concomitant medication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False