The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets in participant population. The main questions it aims to answer are: * Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants. * Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom outcomes. * Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants will 1. take orally Jitongning tablets or a simulated agent of Jitongning tablets. 2. Receive examinations and follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
408
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGBeijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGTongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGSuzhou Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu, China
RECRUITINGAffiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
RECRUITINGThe First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
RECRUITINGYunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
RECRUITINGASAS20
Proportion of subjects who achieved improvement in ASAS20(Assessment of Spondylarthritis International Society) at week 8 of treatment. The ASAS Improvement Criteria contains the following 4 assessment domains: 1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index); 2. Spinal pain, by Spinal Pain Scale; 3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment) 4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged. ASAS 20% response criteria (ASAS 20): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 10 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 20% improvement from baseline.
Time frame: 8 weeks
ASAS20
Proportion of subjects who achieved improvement in ASAS20 at week 4 of treatment.The ASAS Improvement Criteria contains the following 4 assessment domains: 1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index); 2. Spinal pain, by Spinal Pain Scale; 3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment) 4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged. ASAS 20% response criteria (ASAS 20): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 10 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 20% improvement from baseline.
Time frame: 4 weeks
ASAS40
Proportion of subjects who achieved improvement in ASAS40 at week 8 of treatment.The ASAS Improvement Criteria contains the following 4 assessment domains: 1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index); 2. Spinal pain, by Spinal Pain Scale; 3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment) 4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged. ASAS 40% response standard (ASAS 40): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 20 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 40% improvement from baseline.
Time frame: 8 weeks
spinal pain scale
Change from baseline in score of spinal pain at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
Time frame: 8 weeks
BASFI
Change from baseline in score of BASFI(Bath Ankylosing Spondylitis Functional Index) at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
Time frame: 8 weeks
PGA
Change from baseline in score of PGA(Patient Global Assessment) at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
Time frame: 8 weeks
BASDAI
Change from baseline in score of BASDAI(Bath Ankylosing Spondylitis Disease Activity Index) at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.
Time frame: 8 weeks
Traditional Chinese medical Syndrome Points
Change from baseline in score of traditional Chinese medical Syndrome at week 8 of treatment.The scale has a maximum score of 36 points and a minimum score of 0 points, with lower scores indicating milder TCM symptoms.
Time frame: 8 weeks
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