Study of Jitongning Tablet to Treat Spondyloarthritis

Tasly Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Spondyloarthritis

Treatments: Drug: Jitongning tablet(High-dose ); Drug: Jitongning tablet(Low-dose ); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03932019

TSL-TCM-JTNP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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:

  1. BASDAI score ≥ 4;
  2. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 3 patient groups, including a placebo group

Jitongning tablet High dose group

Experimental group

Description:

Jitongning tablet,3tablets,bid,po

Treatment:

Drug: Jitongning tablet(High-dose )

Jitongning tablet Low dose group

Experimental group

Description:

Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po

Treatment:

Drug: Jitongning tablet(Low-dose )

Placebo Comparator controlled group

Placebo Comparator group

Description:

Placebo Comparator: Jitongning tablet placebo,3tablets,bid,po

Treatment:

Drug: Placebo