Ankylosing Spondylitis
Conditions
Interventions
Treatment group:Bushentongluo Formula
Sponsors
Wangjing hospitail of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. There is a clear diagnosis of ankylosing spondylitis, which conforms to the syndrome of kidney deficiency and insufficiency, and is at a moderate disease activity level, with an ASDAS score of (1.3 = ASDAS < 2.1); 2. Age = 18 years and = 70 years; no gender restrictions; 3. If the patient is receiving treatment related to ankylosing spondylitis (such as using slow-acting drugs to control the condition or biologics), they must have maintained the treatment plan (drug type and dosage) stable for more than 3 months, and promise to continue maintaining it unchanged during the trial; patients who have not received the above treatment also meet the inclusion criteria for this study; 4. Voluntarily participate in this study, be able to cooperate with blood sampling and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with other autoimmune diseases; 2. Those with hematological disorders; 3. Those with tumor diseases, severe organ lesions, or mental illnesses; 4. Those who used glucocorticoids within 1 month before the first administration of the test drug; those who newly added or switched to slow-acting anti-rheumatic drugs (DMARDs) or biological agents within 3 months; 5. Those who are known to have tuberculosis, HIV, hepatitis B, hepatitis C, syphilis, or other active or chronic persistent infections; 6. Those who have drug allergies or contraindications specified in the study protocol; 7. Those who received live vaccines within 4 weeks before screening or received inactivated vaccines within 2 weeks before screening, or those with a vaccination plan during the trial; 8. Those with any of the following conditions in the auxiliary examinations at screening: 1) AST or ALT > 1.5 times the upper limit of the normal reference value, or estimated glomerular filtration rate (eGFR) = 60 mL/min/1.73m2; 2) Hemoglobin < 90 g/L, or white blood cell count < 3.0 × 109/L, or neutrophil count < 1.5 × 10^9/L, or lymphocyte count < 0.5 ×10^9/L, or platelet count < 90 × 10^9/L; 9. Those who have undergone major surgery within 2 weeks or whose surgical wounds have not healed; 10. Pregnant or lactating women, those with a fertility plan, or those planning to donate sperm or eggs; 11. Those who are participating in other clinical trials before screening; 12. Those considered by the investigator to have other factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On the 28 ± 2 day of treatment, the change value of the ASDAS score compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change values of the BASDAI score during the treatment period compared with the baseline score;The median time for efficacy to take effect;The change in VAS score during treatment compared to the baseline value;The physician's assessment of the overall treatment response of the patient at 0 days and 28 ± 2 days after the patient took the medication.;The physician conducted an assessment of the "tenderness" of the joint that was most affected by the medication in the patient on days 0 and 28 ± 2 after the patient took the medication.;The assessment of the patient's disease activity of Behcet's ankylosing spondylitis was conducted on days 0 and 28 ± 2 after the administration of the medication.;The assessment of the patient's Barriès functional index for ankylosing spondylitis was conducted on the 0th and 28 ± 2nd days after medication administration.;Compared with the baseline, the changes in the traditional Chinese medicine symptom scores on the 0th and 28 ± 2 days after the patients started taking the medication;Compared with the baseline, the changes in the comprehensive health score at 0 days and 28 ± 2 days after the patients started taking the medication;The changes in CRP and ESR values of the patient on the 0th and 28 ± 2nd days after taking the medication; | — |
Countries
China
Contacts
Public ContactHongli Wang
Wangjing hospitail of China Academy of Chinese Medical Sciences
Outcome results
None listed