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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
238
Jitongning tablet,3tablets,bid,treat 12 weeks
Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks
Jitongning tablet placebo,3tablets,bid,treat 12 weeks
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
ASAS 20 response
The percentage of subjects who achieved ASAS 20 response at 12th weeks
Time frame: 12 weeks
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).
Time frame: 4 weeks,8weeks,12weeks
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).
Time frame: 4 weeks,8weeks,12weeks
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).
Time frame: 4 weeks,8weeks,12weeks
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).
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Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of hunan Medical University
Changsha, Hunan, China
Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine
Nanjing, Jiangsu, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Yunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
...and 1 more locations
Time frame: 4 weeks,8weeks,12weeks
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).
Time frame: 4 weeks,8weeks,12weeks
CRP/hsCRP and ESR
the changes of CRP/hsCRP and ESR at each visit compared to baseline
Time frame: 4 weeks,8weeks,12weeks
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).
Time frame: 12weeks