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A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
Sponsor: Tasly Pharmaceutical Group Co., Ltd
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
Conditions
Interventions
Jitongning tablets
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
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