Study of Jitongning Tablet to Treat Spondyloarthritis

Spondyloarthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932019
• Other study ID #: TSL-TCM-JTNP-01
• Status: Completed
• Phase: Phase 2
• Start date: June 11, 2019
• Est. completion date: August 20, 2021

Study information

• Verified date: November 2022
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: August 20, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)~?(B) (including I(A) and ?(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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Drug:
• Jitongning tablet(High-dose )
Jitongning tablet,3tablets,bid,treat 12 weeks
• Jitongning tablet(Low-dose )
Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks
• Placebo
Jitongning tablet placebo,3tablets,bid,treat 12 weeks

Locations

Country	Name	City	State
China	The First Affiliated Hospital of hunan Medical University	Changsha	Hunan
China	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	Guangzhou	Guangdong
China	The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine	Hefei	Anhui
China	Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Yunnan Province Hospital of Traditional Chinese Medicine	Kunming	Yunnan
China	Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine	Nanjing	Jiangsu
China	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai
China	The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASAS 20 response	The percentage of subjects who achieved ASAS 20 response at 12th weeks	12 weeks
Secondary	BASDAI	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).	4 weeks,8weeks,12weeks
Secondary	BASFI	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).	4 weeks,8weeks,12weeks
Secondary	Spinal pain	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 weeks,8weeks,12weeks
Secondary	PGA	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).	4 weeks,8weeks,12weeks
Secondary	TCM syndrome scores	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).	4 weeks,8weeks,12weeks
Secondary	CRP/hsCRP and ESR	the changes of CRP/hsCRP and ESR at each visit compared to baseline	4 weeks,8weeks,12weeks
Secondary	Exposure of ibuprofen sustained release capsules	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).	12weeks