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A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo

NCT06000956 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2024-11-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Jitongning tablets

The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.

DRUG

a simulated agent of Jitongning tablets

The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.

Sponsors & Collaborators

  • Tasly Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2026-12-01
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000956 on ClinicalTrials.gov