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Clinical study of Tongdu Shujin decoction in the treatment of ankylosing spondylitis with cold-dampness obstruction type: Study protocol for a randomized controlled trial

Clinical study of Tongdu Shujin decoction in the treatment of ankylosing spondylitis with cold-dampness obstruction type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067535
Enrollment
Unknown
Registered
2023-01-10
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Ankylosing spondylitis

Interventions

Treatment group:Tongdu Shujin decoction
Control group :Celecoxib capsules and thalidomide tablets

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Western medical diagnostic criteria for AS; (2) TCM dialectic is cold-dampness obstruction type; (3) 18-40 years old, male or female; (4) Women of childbearing age proved to be not pregnant after testing, and there was no pregnancy plan during the entire trial period; (5) Not taking any AS treatment drugs in the 1 month period before receiving treatment; (6) Voluntarily participate in this trial and agree to enter the clinical study, sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) patients with other rheumatic immune system diseases; (2) Those with serious diseases such as heart, brain, lung, liver, kidney, tumor, infection or hematopoietic system; (3) Patients who are taking other Chinese medicine treatment for certain diseases; (4) Lactating or pregnant women; (5) Those who are allergic to the drugs in this test; (6) Patients with mental disorders who cannot communicate effectively; (7) Those who are active peptic ulcer, bleeding or sulfa allergy; (8) Patients with severe heart failure; (9) Patients with perioperative pain during coronary artery bypass graft.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale;Bath Ankylosing Spondylitis Disease Activity Index;Bath ANKYLOSING Spondylitis Functional Index;

Secondary

MeasureTime frame
Erythrocyte sedimentation rate;C-reactive protein;Spinal range of motion ( including finger-ground distance, occipital tubercle-wall distance, Schober test );

Countries

China

Contacts

Public ContactZihua Wang

The First Affiliated Hospital of Henan University of Chinese Medicine

wzh_010@126.com18838112169

Outcome results

None listed

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