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RECRUITING
NCT06000956
PHASE3

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

Sponsor: Tasly Pharmaceutical Group Co., Ltd

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2023-09-11

Completion Date

2026-12-31

Last Updated

2024-11-21

Healthy Volunteers

No

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.

Locations (10)

Dongfang Hospital, Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Beijing, Beijing Municipality, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Suzhou Hospital of Traditional Chinese Medicine

Suzhou, Jiangsu, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Yunnan Province Hospital of Traditional Chinese Medicine

Kunming, Yunnan, China