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Clinical study for the 'Wen-Yang Tong-Du' medicine pot in the treatment of ankylosing spondylitis

Phase 1
Conditions
Ankylosing Spondylitis
Registration Number
ITMCTR1900002422
Lead Sponsor
Gansu Provincial Hospital of TCM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Meet the diagnostic criteria for ankylosing spondylitis in Western medicine;
2. those who meet the syndrome of kidney deficiency and cold syndrome;
3. aged between 18 and 40 years old, low back pain for at least 3 months;
4. disease activity >=4 weeks;
5. BASDAI score >4 points;
6. arthritis: bilateral II ~ IV or unilateral III ~ IV or MRI suggest ankle joint active (acute) inflammation;
7. Volunteer to participate in the trial and agree to enter the clinical study and sign the informed consent form.

Exclusion Criteria

1. pregnant or lactating women and allergic to this drug;
2. combined with severe primary diseases such as cerebrovascular, cardiovascular, liver, kidney and hematopoietic system, and mental patients;
3. active infection, lower extremity ulcer, tuberculosis, natural joint or artificial joint septic arthritis within 12 months, and persistent or recurrent pulmonary infection or urinary catheter;
4. In the late stage, the spine was severe, the joints were severely deformed, stiff, and lost labor;
5. other seronegative spondyloarthropathy, or patients with other rheumatism;
6. patients with impaired skin integrity, is not suitable for cupping treatment.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
TCM symptoms;Ankle CT;
Secondary Outcome Measures
NameTimeMethod
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