Ankylosing Spondylitis
Conditions
Interventions
Intervention Group:Oral Kidney Supplementation Formula, consisting of Gouji, Shudihuang, Gusuibu, Fuzi, Lujiaoshuang, etc., one dose daily, taken in the morning and evening, for 12 weeks. The interven
Control Group:Oral Chinese herbal placebo, consisting of caramel color 0.0018, bittering agent 0.00003, xanthan gum 0.003, and Chinese herbal liquid up to a maximum of 10%, one dose daily, taken in th
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years; 2. Diagnosed with AS according to the 1984 revised New York criteria of the American Rheumatism Association or the 2009 axial spondyloarthritis classification criteria of the Assessment of Spondyloarthritis International Society (ASAS); 3. Patients who have received biologic therapy and experienced disease recurrence during the tapering phase of biologic treatment; 4. Meet the criteria for active AS: ASDAS-CRP = 2.1; (ASAS-CRP calculation formula: 0.12 × spinal pain + 0.06 × morning stiffness duration + 0.11 × patient assessment + 0.07 × peripheral joint swelling and pain score + 0.58 × Ln(CRP + 1)). 5. TCM syndrome differentiation is "Kidney Deficiency andCold Syndrome," referring to the "Treatments for(Ankylosing Spondylitis) in Traditional Chinese Medicine" issued by the National Administration of Traditional Chinese Medicine (2017 edition) and the "Collaborative Diagnosis and Treatment Plan for(Ankylosing Spondylitis) of the Rheumatism Specialty Collaboration Group during the 11th Five-Year Plan of the National Administration of Traditional Chinese Medicine": Main symptoms: 1) Low back, spine, buttock pain, stiffness, and discomfort; 2) Fear of cold and preference for warmth, with relief upon warming. Secondary symptoms: 1) Limited flexion and extension, impaired mobility; 2) Fatigue, soreness of waist and knees; 3) Coldness in male scrotum, cold and slippery leukorrhea in females; 4) Loose stools, clear and long urine. Diagnosis can be made if 2 main symptoms and 1 secondary symptom are present, along with a pale red or dark red tongue, thin white or thick white coating, and a deep string-like or deep string-like and fine pulse, with weak pulse at the cun position. 6. Voluntarily signed the informed consent form. 7. If patients have been regularly using traditional synthetic disease-modifying antirheumatic drugs (csDMARDs) and have been on a stable dose for more than 12 weeks prior to enrollment, they may continue using the drug after enrollment with no change in dose for 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, patients with mental illness, patients with severe malnutrition, or patients with severe impairment of the heart, brain, kidney, or hematopoietic system; 2. Patients with other seronegative spondyloarthropathies or other rheumatic diseases; 3. Patients with advanced spinal or hip joint disease requiring surgical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20 response rate at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS40 response rate at week 12;ASDAS-CRP at Week 12;Symptoms and Signs;TCM Syndrome Score;Disease Activity;Quality of Life Change;NSAIDs Intake Scoring;The first time achieving ASAS20 response.; | — |
Countries
China
Contacts
Public ContactWeiping Kong
China-Japan Friendship Hospital
Outcome results
None listed