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Clinical observation on the treatment of ankylosing spondylitis with kidney deficiency and supervisory cold type by Fuzi Guizhi prescription

Clinical observation on the treatment of ankylosing spondylitis with kidney deficiency and supervisory cold type by Fuzi Guizhi prescription

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085040
Enrollment
Unknown
Registered
2024-05-30
Start date
2024-06-06
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankylosing spondylitis

Interventions

experimental group:Functional exercise based on conventional care and medication+ Fuzi Guizhi prescription
control group:Functional exercise based on conventional care and medication

Sponsors

Yunnan Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years old (including 18 & 65 years old), gender is not limited; 2. Meet the diagnostic criteria of axial spondyloarthritis recommended by ASAS in 2009; 3. Meet the Chinese medicine diagnostic criteria of kidney deficiency and cold syndrome; 4. CT examination of sacroiliac arthritis grades ? (A) to ? (B) (both inclusive); 5. Human leukocyte antigen B27 (HLA-B27) positive; 6. Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have received Chinese medicines other than salazosulfapyridine for the treatment of this disease, chemical drugs (such as methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide, etc.), opioid analgesic drugs (such as morphine, etc.), JAK inhibitor drugs (such as tofacitabine, etc.), and all glucocorticosteroids in 4 weeks prior to the enrollment; 2. 8 weeks prior to enrollment has received spinal or joint surgical treatment; 3. Use of biologics with therapeutic effects on spondyloarthritis within 12 weeks prior to enrollment; 4. CT suggesting loss of sacroiliac joint space or spinal ankylosis; 5. Confirmed concomitant other rheumatic immune system diseases or immunodeficiency syndromes, such as active ulcerative colitis, psoriasis and uveitis; 6. Those who have reproductive requirements within six months; 7. Pregnant or lactating women; 8. Suspected or confirmed drug addiction, drug abuse, alcoholism; 9. Within 3 months prior to the trial or are participating in a clinical trial; 10. Serious heart, liver, kidney, brain, mental, neurological disorders that affect informed consent or adverse event expression or observation; abnormal liver function (glutamic or alanine aminotransferase level higher than the upper limit of normal value); abnormal kidney function (serum creatinine level higher than the upper limit of normal value).

Design outcomes

Primary

MeasureTime frame
ASAS 20% Response Standard (ASAS20);

Secondary

MeasureTime frame
Erythrocyte sedimentation rate, ESR;C-reactive protein, CRP;Interleukin 6,IL-6;Kidney function test;Liver function test;Sacroiliac CT;HLA-B27;

Countries

China

Contacts

Public ContactTang Xiaohu

Yunnan Hospital of Traditional Chinese Medicine

tigerlet-tcm@126.com+86 130 6421 4246

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026