NCT03932019CompletedPhase 2
A Randomized, Double-blind, Placebo-controled, Multi-center Phase II Clinical Trial for Evaluation of the Efficacy and Safety of Jitongning Tablet in Patients With Active Axial Spondyloarthritis(SpA)
Tasly Pharmaceutical Group Co., Ltd11 sites in 1 country238 target enrollmentStarted: June 11, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 238
- Locations
- 11
- Primary Endpoint
- ASAS 20 response
Study Overview
Brief Summary
This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage.
Detailed Description
Jitongning Tablet is a kind of traditional Chinese medicine(TCM), consists of Cortex Eucommiae, Duhuo(Radix Angelicae Pubescentis), Zhichuanwu(Radix Aconiti) , Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Puerariae and Radix Glycyrrhizae. This study is being conducted to evaluate the efficacy and safety of Jitongning Tablet in patients with active axial spondyloarthritis (SpA) (Syndrome Of Kidney Yang Deficiency and Biood Stasis Stagnation), when compared with placebo and to explore the optimal dosage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women aged 18 to 65 years old (including 18 and 65) ;
- •Meeting the diagnostic criteria for active axial SpA according to the the ASAS classification 2009, defined as satisfied 2 of the following:
- •BASDAI score ≥ 4;
- •In the assessment of pain numerical rating scale (NRS), spine pain NRS ≥ 4;
- •Meeting the standard of TCM syndrome diagnosis for kidney yang deficiency and biood stasis stagnating syndrome;
- •Sacroiliac arthritis of CT categories I(A)~Ⅲ(B) (including I(A) and Ⅲ(B));
- •Human leukocyte antigen B27 (HLA-B27) is positive;
- •C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate raised;
- •Voluntary signing of informed consent.
Exclusion Criteria
- •Those who use NSAIDs in the first 2 weeks of randomization;
- •In the first 4 weeks of randomization, take disease-modifying antirheumatic Chinese herbal medicine or Chemical drugs (such as sulfasalazine ,methotrexate, leflunomide, Chloroquine, Total glycosides of Tripterygium, Cyclophosphamide, Azathioprine, etc),opioid analgesics(Methadone, Morphine, etc.) ,systemic glucocorticoid therapy;
- •In the first 3 months of randomization, take biological agents that have been used for spinal arthritis;
- •Those who have undergone spinal surgery or joint surgery within 8 weeks before randomization;
- •Patients who received intra-articular injection, spinal or paravertebral injection of corticosteroids within the first 6 months of randomization;
- •The spine is completely stiff (fused);
- •Any Other rheumatic immune system diseases or immunodeficiency syndromes such as ulcerative colitis, psoriasis, uveitis, etc.
- •Those who have a fertility requirement within 6 months;
- •Women during pregnancy and lactation;
- •Suspected or indeed drug use, substance abuse, alcoholism;
- •In the first 3 months of randomization, take the test or in progress;
- •Serious cardiovascular, Liver , kidney, brain, mental, neurological disorders that affect informed consent and/or adverse event expression or observation;
- •Abnormal liver function(the AST or ALT value is above the upper limit of the normal); Abnormal renal function (serum creatinine is above the upper limit of normal);
- •Due to other circumstances, the investigator considered it inappropriate for the participants.
Arms & Interventions
Jitongning tablet High dose group
Experimental
Jitongning tablet,3tablets,bid,po
Intervention: Jitongning tablet(High-dose ) (Drug)
Jitongning tablet Low dose group
Experimental
Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po
Intervention: Jitongning tablet(Low-dose ) (Drug)
Placebo Comparator controlled group
Placebo Comparator
Placebo Comparator: Jitongning tablet placebo,3tablets,bid,po
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
ASAS 20 response
Time Frame: 12 weeks
The percentage of subjects who achieved ASAS 20 response at 12th weeks
Secondary Outcomes
- BASDAI(4 weeks,8weeks,12weeks)
- BASFI(4 weeks,8weeks,12weeks)
- Spinal pain(4 weeks,8weeks,12weeks)
- PGA(4 weeks,8weeks,12weeks)
- TCM syndrome scores(4 weeks,8weeks,12weeks)
- Exposure of ibuprofen sustained release capsules(12weeks)
- CRP/hsCRP and ESR(4 weeks,8weeks,12weeks)
Investigators
Study Sites (11)
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