Actively Recruiting
A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-11-21
408
Participants Needed
10
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Diagnosed with active axial osteoarthritis according to ASAS 2009 criteria
- Disease activity with BASDAI score of at least 40 mm and spinal pain score of at least 40 mm on a 0-100 mm scale
- Meet traditional Chinese medicine criteria for kidney yang deficiency and blood stasis obstruction syndrome
- CT scan showing sacroiliac arthritis grades I (A) to II (B)
- Positive for human leukocyte antigen B27 (HLA-B27)
- Elevated C-reactive protein or erythrocyte sedimentation rate
- Willing to participate and provide informed consent
You will not qualify if you...
- Use of non-steroidal anti-inflammatory drugs within 2 weeks before enrollment
- Use of certain traditional Chinese medicines, chemical drugs, opioid analgesics, JAK inhibitors, or systemic glucocorticoids within 4 weeks before enrollment
- Spinal or joint surgery within 8 weeks before enrollment
- Use of biological agents for spinal arthritis within 12 weeks before enrollment
- Corticosteroid injections into joints or spine within 6 months before enrollment
- CT showing disappearance of sacroiliac joint space or complete spinal rigidity
- Diagnosis of other rheumatic or immune diseases such as ulcerative colitis, psoriasis, or uveitis
- Planning to conceive within 6 months
- Pregnant or breastfeeding women
- History or suspicion of drug, substance, or alcohol abuse
- Participation in other clinical trials within 3 months before or currently
- Serious heart, liver, kidney, brain, mental, or neurological disorders affecting consent or safety monitoring
- Abnormal liver or kidney function tests
- Investigator's judgment that participation is unsuitable
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China, 100078
Actively Recruiting
2
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
3
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
4
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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5
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Actively Recruiting
6
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
7
Suzhou Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu, China
Actively Recruiting
8
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Actively Recruiting
9
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Actively Recruiting
10
Yunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
Actively Recruiting
Research Team
W
Wei Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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