Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine
- Conditions
- Ankylosing Spondylitis
- Registration Number
- ITMCTR2100004334
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) The study subjects should meet the following diagnostic criteria: ? Western medical diagnostic criteria: New York criteria revised by the American College of Rheumatology in 1984;(2) TCM syndrome diagnosis criteria: according to Professor Jiao Shude's Big Stoop (Ankylosing Spondylitis) Etiology, Pathogenesis and Syndrome Differentiation Discussion revised.
(2) Active patients with ankylosing spondylitis (Basdai >4);
(3) Aged 18-70 years(inclusive)
(4) The use of NSAIDs has been stopped for 2 weeks;
(5) The use of remission anti-rheumatic drugs (DMARDs) has been stopped for 1 month;
(6) The use of biological agents has been stopped for 3 months;
(7) Signed the informed consent.
Potential subjects meeting the inclusion criteria will be excluded if they meet any of the following criteria:
(1) Peripheral articular AS (classification standard of AS according to 2009ACR);
(2) Patients with advanced disease, complete spine rigidity and severe joint deformity indicated by clinical or imaging;
(3) The baseline examination showed abnormal platelet, white blood cell and hemoglobin in the following laboratory indicators, which had clinical significance;Serum creatinine, AST, ALT, ALP, GGT, TBIL were 1.25 times higher than normal.The urine routine was abnormal, and the erythrocyte > / HP and occult blood were positive in stool routine, which had clinical significance.
(4) Pregnant women, lactating women, or women who intend to become pregnant within one year;
(5) Participating in other clinical trials;
(6) Those who have received treatment under this plan but have no effect;
(7) Patients with severe primary heart, liver, kidney and other organ function impairment or other possible interference with follow-up evaluation;
(8) The researchers believe that they cannot enter the clinical researchers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ASAS20;
- Secondary Outcome Measures
Name Time Method MASES;ALP, Ca, P;BASFI;PSQI;ASQoL;PGA;FSFI;BASDAI;FACIT-Fatigue;HADS;ESR;IIEF;spine pain;BASMI;CRP;