A 48 Week Randomized Controlled Trial to Evaluate the Clinical Outcomes of Ankylosing Spondylitis Managed by Chinese Medicine Compared with Western Medicine, a pilot study.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13004564

Enrollment

Unknown

Registered

2013-07-05

Start date

2007-07-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Ankylosing Spondylitis

Interventions

CM:Decoction of Chinese herbs + Moxibustion on 'Governor Vessel (GV)' + standard AS exercise regimen

WM treatment group:Celecoxib 200mg twice daily + standard AS exercise regimen

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with active ankylosing spondylitis (AS)conform to western medicine diagnostic criteria(BASDAI > 4, with VAS pain scale of > 40/100); 2. In accordance with ankylosing spondylitis standard syndromes of traditional Chinese medicine; 3. Older than 18 years of age.

Exclusion criteria

Exclusion criteria: Exclusion criteria will include the following: 1. Peripheral joint disease as defined by pain or swelling of any peripheral joints (excluding shoulders and hips if shoulder or hip pain is thought to be referred pain from the spine); 2. unable to provide informed consent; 3. unwilling or unable to comply with treatment or assessment regimen; 4. participating in another clinical trial; 5. abnormal baseline laboratory results (to be done in one laboratory) including; (1) platelet count less than 150 x 10^9/L; (2) white blood cell count less than 4.0 x 10^3/mm3; (3) polymorphonuclear leukocyte cell count less than 1.5 x 10^3/mm3; (4) hemoglobin less than 100g/L; (5) serum creatinine greater than 104umol/L; (6) AST, ALT, alkaline phosphatase greater than 2 times upper limit of normal for local laboratory; 6. abnormal urinalysis which would indicate severe or uncontrolled co-morbid conditions which wil likely compromise patient evaluation; 7. women who are breast feeding; 8. women currently pregnant, or who are planning on becoming pregnant during the study period; 9. severe co morbid conditions likely to compromise follow up evaluation.

Design outcomes

Primary

Measure	Time frame
Ankylosing spondylitis disease activity score (ASDAS);	—

Secondary

Measure	Time frame
CRP;ESR;Bath Ankylosing Spondylitis Disease Activity Index;BASFI;BASMI;SF36;PGA;VAS;	—

Countries

China

Contacts

Public ContactYiting He

Guangdong Provincial Hospital of Chinese Medicine

yitinghe@126.com+86 13922178769

Outcome results

None listed

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