Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT06000956
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2023-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Protocol of the Efficacy and Safety of Jitongning Tablets for Treating Spondyloarthritis (Kidney Yang Deficiency and Blood Stasis Obstruction)
Status:
RECRUITING
Status Verified Date:
2024-11
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 goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets in participant population. The main questions it aims to answer are:
* Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants.
* Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom outcomes.
* Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants will
1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.
2. Receive examinations and follow-up visits.
* Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants.
* Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom outcomes.
* Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants will
1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.
2. Receive examinations and follow-up visits.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: