Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of Jitongning Tablets for Treating Spondyloarthritis with Kidney Yang Deficiency and Blood Stasis Obstruction
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-11-21
408
Participants Needed
10
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Jitongning tablets in adults with active axial spondyloarthritis (ax-SpA). The study aims to determine if Jitongning tablets can improve symptoms and functions better than a placebo. It also assesses the safety of the tablets in this patient population. The trial is a randomized, double-blind, placebo-controlled Phase III study sponsored by Tasly Pharmaceutical Group Co., Ltd.
CONDITIONS
Brief 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 based on ASAS 2009 criteria
- Disease activity with BASDAI score of at least 40mm and spinal pain score of at least 40mm on a visual scale
- Meets traditional Chinese medicine syndrome criteria for kidney yang deficiency and blood stasis obstruction
- CT 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
- Voluntary participation with signed informed consent form
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 in joint or spine areas within 6 months before enrollment
- CT showing disappearance of sacroiliac joint space or complete spinal rigidity
- Diagnosis of other rheumatic immune diseases or immune deficiency syndromes
- Fertility plans within six months
- Pregnancy or breastfeeding
- Suspected or actual substance or alcohol abuse
- Participation in other clinical trials within 3 months
- Serious heart, liver, kidney, brain, mental, or neurological disorders affecting consent or safety
- Abnormal liver or kidney function above normal limits
- Any condition deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take three tablets of Jitongning tablets or placebo orally, twice a day, for 8 consecutive weeks.
Visits as scheduled during the 8-week treatment period
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
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3
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
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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
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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
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9
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
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10
Yunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
Actively Recruiting
Research Team
W
Wei Liu
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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