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Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine

Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004334
Enrollment
Unknown
Registered
2021-01-28
Start date
2021-02-01
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

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) The study subjects should meet the following diagnostic criteria: ? Western medical diagnostic criteria: New York criteria revised by the American College of Rheumatology in 1984;(2) TCM syndrome diagnosis criteria: according to Professor Jiao Shude's "Big Stoop (Ankylosing Spondylitis) Etiology, Pathogenesis and Syndrome Differentiation Discussion" revised. (2) Active patients with ankylosing spondylitis (Basdai >4); (3) Aged 18-70 years(inclusive) (4) The use of NSAIDs has been stopped for 2 weeks; (5) The use of remission anti-rheumatic drugs (DMARDs) has been stopped for 1 month; (6) The use of biological agents has been stopped for 3 months; (7) Signed the informed consent.

Exclusion criteria

Exclusion criteria: Potential subjects meeting the inclusion criteria will be excluded if they meet any of the following criteria: (1) Peripheral articular AS (classification standard of AS according to 2009ACR); (2) Patients with advanced disease, complete spine rigidity and severe joint deformity indicated by clinical or imaging; (3) The baseline examination showed abnormal platelet, white blood cell and hemoglobin in the following laboratory indicators, which had clinical significance;Serum creatinine, AST, ALT, ALP, GGT, TBIL were 1.25 times higher than normal.The urine routine was abnormal, and the erythrocyte > / HP and occult blood were positive in stool routine, which had clinical significance. (4) Pregnant women, lactating women, or women who intend to become pregnant within one year; (5) Participating in other clinical trials; (6) Those who have received treatment under this plan but have no effect; (7) Patients with severe primary heart, liver, kidney and other organ function impairment or other possible interference with follow-up evaluation; (8) The researchers believe that they cannot enter the clinical researchers.

Design outcomes

Primary

MeasureTime frame
ASAS20;

Secondary

MeasureTime frame
MASES;ALP, Ca, P;BASFI;PSQI;ASQoL;PGA;FSFI;BASDAI;FACIT-Fatigue;HADS;ESR;IIEF;spine pain;BASMI;CRP;

Countries

China

Contacts

Public ContactHe Yiting

Guangdong Provincial Hospital of Chinese Medicine

yitinghe@126.com+86 13922178769

Outcome results

None listed

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