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Study of Jitongning Tablet to Treat Spondyloarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03932019
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Spondyloarthritis Drug: Jitongning tablet Drug: Jitongning tablet,Jitongning tablet placebo Drug: Jitongning tablet placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: High dose group
Jitongning tablet,3tablets,bid,po
Drug: Jitongning tablet
Jitongning tablet,3tablets,bid,treat 12 weeks

Experimental: Low dose group
Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po
Drug: Jitongning tablet,Jitongning tablet placebo
Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks

Placebo Comparator: Placebo Comparator controlled group
Placebo Comparator: Jitongning tablet placebo,3tablets,bid,po
Drug: Jitongning tablet placebo
Jitongning tablet placebo,3tablets,bid,treat 12 weeks




Primary Outcome Measures :
  1. ASAS 20 response [ Time Frame: 12 weeks ]
    The percentage of subjects who achieved ASAS 20 response at 12th weeks


Secondary Outcome Measures :
  1. BASDAI [ Time Frame: 4 weeks,8weeks,12weeks ]

    the score changes of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at each visit compared to baseline.

    This instrument consists of six 10cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. The mean of which gives the BASDAI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).


  2. BASFI [ Time Frame: 4 weeks,8weeks,12weeks ]

    the score changes of Bath Ankylosing Spondylitis Functional Index (BASFI) at each visit compared to baseline.

    This instrument consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).


  3. Spinal pain [ Time Frame: 4 weeks,8weeks,12weeks ]
    the score changes of Spinal pain at each visit compared to baseline. Spinal pain was scored as the average of two VAS questions about total spinal pain and nocturnal spinal pain. The mean of which gives the spinal pain score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).

  4. PGA [ Time Frame: 4 weeks,8weeks,12weeks ]
    the score changes of PGA at each visit compared to baseline. Patient global assessment was measured using a set of visual analogue scales (VAS) on which patients rated the severity of their disease from 0 (none) to 10 (most severe).

  5. TCM syndrome scores [ Time Frame: 4 weeks,8weeks,12weeks ]
    the score changes of TCM syndrome scores at each visit compared to baseline. This instrument consists of three primary symptoms: spinal pain, spinal function limited, morning stiffness and six secondary symptoms: nocturnal back pain、stabbing pain、Local cold pain、aversion to cold,preference for heat、heel pain、weakness in the lower back and knees. Four levels to measure severity of primary symptoms(0、2、4、6)and secondary symptoms(0、1、2、3), respectively. Record the tongue and pulse conditions. The final score has a range of 0 to 100. The severity of patient's symptoms from 0 (none) to 100(most severe).The TCM syndrome effect calculated by nimodipine method. The effect of TCM syndrome from negative (worsen) to 100% (disappear).

  6. CRP/hsCRP and ESR [ Time Frame: 4 weeks,8weeks,12weeks ]
    the changes of CRP/hsCRP and ESR at each visit compared to baseline

  7. Exposure of ibuprofen sustained release capsules [ Time Frame: 12weeks ]

    Exposure of ibuprofen sustained release capsules in test group and placebo at 12th weeks.

    Exposure of ibuprofen sustained release capsules refers to the quantity of ibuprofen capsules patient actually took. The difference between the total dispensed quantity and the sum of recycling quantity and missing quantity gives the exposure of ibuprofen sustained release capsules. The exposure of ibuprofen sustained release capsules from 0 (none) to 372 (maximum).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932019


Contacts
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Contact: Rui Liu 022-86343626 liurui2@tasly.com
Contact: Ning Dai 022-86343653 daining@tasly.com

Locations
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China, Anhui
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Recruiting
Hefei, Anhui, China
Contact: Chuanbing Huang    13865922531    chuanbinh@163.com   
China, Guangdong
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China
Contact: Changsong Lin    13802772276      
China, Hubei
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Shenghao Tu    13971535353    shtu@tjh.tjmu.edu.cn   
China, Hunan
The First Affiliated Hospital of hunan Medical University Recruiting
Changsha, Hunan, China
Contact: Shenzhi Wang    13808469631    361979636@qq.com   
China, Jiangsu
Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine Recruiting
Nanjing, Jiangsu, China
Contact: Fang Zhang    15312019181    15312019181@163.com   
China, Shandong
Affiliated Hospital of Shandong University of Traditional Chinese Medicine Recruiting
Jinan, Shandong, China
Contact: Ying Liu    13793188170    lytt_1944@163.com   
China, Tianjin
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China
Contact: Wei Liu    022-27986630    fengshiliuwei@163.com   
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China
Contact: Bin Fu    15122679391    doctorfubin@126.com   
China, Yunnan
The First Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China
Contact: Ying Zhang    13708450827    577811010@qq.com   
Yunnan Province Hospital of Traditional Chinese Medicine Recruiting
Kunming, Yunnan, China
Contact: Jiangyun Peng    13099963399    pengjiangyun@126.com   
China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, China
Contact: Jianchun Mao         
Sponsors and Collaborators
Tasly Pharmaceuticals, Inc.
Investigators
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Study Director: Rui Liu Tasly Group, Co. Ltd.

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Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03932019    
Other Study ID Numbers: TSL-TCM-JTNP-01
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tasly Pharmaceuticals, Inc.:
Jitongning Tablet, Spondyloarthritis
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases