Ankylosing Spondylitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESR;CRP;BASDAI;BASFI;BASMI;PGA;spine pain;MASES;ALP, Ca, P;ASQoL;FACIT-Fatigue;HADS;PSQI;IIEF;FSFI; | — |
Countries
China
Contacts
Guangdong Provincial Hospital of Chinese Medicine