A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
NCT ID: NCT06000956
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
408 participants
INTERVENTIONAL
2023-09-11
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Jitongning Tablet to Treat Spondyloarthritis
NCT03932019
A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
NCT07261644
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
NCT06242652
Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS)
NCT01212653
A Study to Evaluate the Efficacy and Safty of 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
NCT07349329
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Jitongning tablets
Jitongning tablets
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
a simulated agent of Jitongning tablets
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
2. Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009, and the condition is in an active phase. The criteria for determining disease activity are to meet two criteria: Bass ankylosing spondylitis disease activity index (BASDAI) ≥ 40mm (0-100mm, evaluated using VAS); Spinal pain score ≥ 40mm (0-100mm, evaluated using VAS);
3. Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;
4. CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);
5. Human leukocyte antigen B27 (HLA-B27) is positive;
6. Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR);
7. Voluntarily participate in this clinical trial and sign an informed consent form.
Exclusion Criteria
1. Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;
2. Within 4 weeks before enrollment, he received traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction, chemical drugs (such as sulfasalazine, methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide, azathioprine, etc.), opioid analgesics (such as methadone, morphine, etc.), JAK inhibitor drugs (such as tofatib, etc.), and systemic glucocorticoid treatment;
3. Received spinal or joint surgery treatment within 8 weeks prior to enrollment;
4. Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;
5. Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area;
6. CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;
7. Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;
8. Those who have fertility requirements within six months;
9. Pregnant or lactating women;
10. Suspected or actual drug, substance, or alcohol abuse;
11. Within 3 months prior to the trial or currently participating in clinical trials;
12. Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events;
13. Abnormal liver function (elevated levels of alanine or alanine aminotransferase above the upper limit of normal values); Abnormal renal function (serum creatinine levels above the upper limit of normal values);
14. The researchers believe that it is not suitable to participate in this experiment.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tasly Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TSL-TCM-JTNP-Ⅲ
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.