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Study to Evaluate the Effect of "Qingre Shuji Decoction" combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with ankylosing spondylitis&#32

Study to Evaluate the Effect of "Qingre Shuji Decoction" combined with Guideline-Directed Medical Treatment on the Quality of Life and Clinical Outcomes in Patients with ankylosing spondylitis&#32

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006555
Enrollment
Unknown
Registered
2022-09-01
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

ankylosing spondylitis

Interventions

control group:Chinese medicine placebo + western medicine standard treatment
test team:Oral Qingreshuji Prescription + Western Medicine Standard Treatment

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?18–75 years old ; ?Patients met the diagnostic criteria of Western medicine and disease activity, and the VAS score of spinal pain (the second item of BASDAI) was = 40 mm. ?Patients who met the diagnostic criteria of kidney deficiency and dampness-heat syndrome in TCM ; ?voluntary signing of informed consent ; ?Drug cleaning : SASP, methotrexate (MTX), leflunomide (LEF) and other antirheumatic drugs, hormones, biological agents or small molecule targeted drugs were not used more than 1 month before randomization.

Exclusion criteria

Exclusion criteria: ?pregnant or lactating women and mental patients with severe malnutrition or severe damage to the heart, brain, kidney and hematopoietic system ; ?patients with other rheumatic diseases ; ?Patients with severe spinal and hip joint dysfunction who needed surgery during this study ; ?Concurrent NSAIDs use contraindications ; ?contraindications for combined use of biological agents.

Design outcomes

Primary

MeasureTime frame
Effective rate of ASAS20 at week 16;

Countries

China

Contacts

Public ContactKong Weiping
kongweiping75@126.com13611038252

Outcome results

None listed

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