NCT06377072

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Shanghai Hutchison Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Spondylotic Myelopathy

Interventions

Type	Name	Description
DRUG	Shenqi Sherong Pill	two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks
DRUG	Placebo	two bags each time, three times a day at half an hour after breakfast, lunch and dinner for 6 weeks

Timeline

• Start date: 2024-05-11
• Primary completion: 2026-01-14
• Completion: 2026-03-01
• First posted: 2024-04-22
• Last updated: 2026-02-04

Locations

1 site across 1 country: China