ankylosing spondylitis
Conditions
Interventions
Intervention group:Qiangji Pill
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. For males and females aged 18-40 (including upper and lower limits), the age calculation shall be based on the date of signing the Informed Consent Form (ICF); 2. Having a clear history of ankylosing spondylitis or meeting the diagnostic criteria for ankylosing spondylitis; 3. The differentiation criteria of traditional Chinese medicine are in line with the syndrome of kidney deficiency and Du cold; 4. BASDAI score >= 4 points; 5. Volunteer to participate in this clinical trial, obtain informed consent and sign an informed consent form, and be able to complete the research procedure.
Exclusion criteria
Exclusion criteria: 1. Patients with complete spinal rigidity; 2. Patients with fibromyalgia or mechanical low back pain, such as lumbar muscle strain, lumbar disc herniation, and other symptoms that cause low back pain; 3. Other inflammatory or autoimmune diseases other than AS, including but not limited to rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, systemic lupus erythematosus, scleroderma or polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjogren's syndrome, immunodeficiency syndrome (such as Felty's syndrome), etc; 4. Patients with progressive or uncontrolled respiratory, circulatory, digestive, urogenital, endocrine, neurological, or psychiatric disorders, or other chronic diseases that are not suitable for participation in this clinical trial study; 5. Chronic recurrent infectious diseases, tuberculosis, lymphoma or other cancers; 6. Individuals with any severe systemic or local infection within 2 months prior to screening; 7. Combined infectious diseases, including but not limited to viral hepatitis, syphilis, AIDS, etc; 8. Abnormal liver and kidney function and blood count; 9. Individuals with a history of AS treatment as follows: (1) Those who have received biologic therapy (with the same drug name counted as one) before enrollment; (2) Individuals who have received intra-articular or paraspinal injections of glucocorticoids, intramuscular or intravenous injections within 4 weeks prior to enrollment; (3) Those who have undergone spinal surgery or joint surgery before enrollment; 10. Participated in any clinical research on other drugs or medical devices within the three months prior to enrollment or currently; 11. History of alcohol or drug abuse or drug use; 12. Pregnant or lactating women; 13. Any medical or mental illness that researchers believe will hinder participants from following the protocol or completing the study according to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the ASAS40 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| the ASAS20 response rate;Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score relative to baseline at the end of the 12th week ± 2 days of medication administration;Reaching a response rate of ASAS 40 at each visit from baseline until the end of treatment at the end of the 12th week ± 2 days (excluding the 12th week ± 2 days after medication administration);From baseline until the end of treatment at the end of the 12th week ± 2 days (excluding the 12th week ± 2 days after medication), achieving a response rate of ASAS20 at each visit;Reaching an ASAS 5/6 response rate at each visit from baseline to the end of treatment at the end of the 12th week ± 2 days;Changes in C-reactive protein (CRP) relative to baseline at each visit from the beginning of the line to the end of the 12th week of medication ± 2 days;Changes in erythrocyte sedimentation rate (ESR) values relative to baseline at each visit from baseline to the end of the 12th week of medication ± 2 days;Changes in PGA scores relative to baseline at each visit from baseline to the end of the 12th week ± 2 days after treatment;Change in total back pain VAS score relative to baseline at each visit from baseline to the end of treatment at the end of the 12th week ± 2 days;Changes in nocturnal pain VAS scores relative to baseline at each visit from baseline to the end of treatment at the end of the 12th week ± 2 days;Changes in chest expansion relative to baseline at each visit from baseline to the end of treatment at the end of the 12th week ± 2 days;Changes in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score relative to baseline at each visit from baseline to the end of treatment at the end of the 12th week ± 2 days (excluding the 12th week ± 2 days after medication administration);Changes in the Bath Ankylosing Spondylitis Measurement Index (BASMI) score relative to baseline at each visit from baseline to the end of the 12th week ± 2 days after treatment;Changes in the | — |
Countries
China
Contacts
Public ContactXie Xincai
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed