Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377072
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-03
Brief Title:
Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy
Sponsor:
Shanghai Hutchison Pharmaceuticals Limited
Organization:
Shanghai Hutchison Pharmaceuticals Limited
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
1 Trial Design This is a multi-center randomized double-blind placebo-controlled phase III studywhich 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None