Clinical Trials Logo
  1. Home
  2. Cervical Spondylotic Myelopathy
  3. NCT06377072

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

Cervical Spondylotic Myelopathy Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06377072
Study type Interventional
Source Shanghai Hutchison Pharmaceuticals Limited
Contact Xiaoling Zhao, master
Phone 02162506452
Email zhaoxiaoling@shpl.com.cn
Status Recruiting
Phase Phase 3
Start date May 11, 2024
Completion date March 2026
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04952831 - Diffusion MRI in Cervical Spondylotic Myelopathy
Completed NCT00565734 - Surgical Treatment of Cervical Spondylotic Myelopathy Phase 4
Completed NCT00506558 - The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy Phase 3
Recruiting NCT00876603 - Anterior Vs Posterior Procedures for Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial N/A
Enrolling by invitation NCT03513679 - Gait in Adult Patients With Cervical Spondylotic Myelopathy N/A
Completed NCT01257828 - Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect) Phase 3
Completed NCT04968054 - Comparison of IONM Between Remimazolam and Propofol N/A
Active, not recruiting NCT03296592 - Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)
Active, not recruiting NCT04955041 - Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy
Completed NCT01061697 - Pregabalin and Radicular Pain Study (PARPS) Phase 4
Completed NCT03810781 - Postural Stability in Cervical Spinal Myelopathy
Recruiting NCT04936074 - Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy N/A
Completed NCT00285337 - Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy N/A
Completed NCT02539394 - Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion N/A
Recruiting NCT05149404 - The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery