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Study on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by Metabolomics

Study on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by Metabolomics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003433
Enrollment
Unknown
Registered
2020-06-26
Start date
2019-04-01
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

Jiangsu Province Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. diagnosed as ankylosing spondylitis: meet the AS New York Standard revised in 1984 or the Central Axis SpA classification standard recommended by the International Society for the Treatment of Spondylitis (ASAS) in 2009; 2. Married, bred, no fertility requirement within one year; 3. aged between 25 and 70 years old; 4. TCM syndrome differentiation is in accordance with the syndrome of kidney deficiency and coldness in Du Meridian [Refer to the "Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine" promulgated in 2002, the "Reference Standard for Syndrome Differentiation of Traditional Chinese Medicine" formulated by the National Committee of Integrative Medicine for Deficiency of Chinese Medicine and Western Medicine, and the "Criteria for Syndrome Differentiation of Traditional Chinese Medicine" edited by Professor Deng Tietao.]: Main symptoms: lumbosacral,stiffness and uncomfortable feeling in lower back, limited activity such as pitching; weakness of waist and knees; avoid of coldness, and comfortable with warmness. Secondary symptoms: the extremities are not warm;loose stool;the scrotum is wet and cold, impotence, and soreness of waist and knees;clear urine or more frequent during the nighttime. Tongue and pulse:pale tongue, thin white coating and deep thready pulse. Two main symptoms are necessary, combined with secondary symptoms, tongue and pulse.

Exclusion criteria

Exclusion criteria: 1. Those who have not given birth or have fertility requirement within one year; 2. History of using any NSAIDs and DMARDs within 12 weeks; 3. Blood WBC <3.5x10^9/L; alanine aminotransferase is more than twice the normal value; 4. Combined with serious primary diseases such as cardiovascular, tumor, kidney, liver and hematopoietic system; 5. Hepatitis B patients; 6. Psoriasis, Crohn's disease, ulcerative colitis, recent onset of ophthalmia; 7. Unable to cooperate.

Design outcomes

Primary

MeasureTime frame
ASAS20, 40;BASDAI;ASDAS;

Secondary

MeasureTime frame
ESR;Metabolomic changes in serum;CRP;

Countries

China

Contacts

Public ContactJi Wei

Jiangsu Province Hospital of TCM

weiweiji1103@163.com+86 13951606616

Outcome results

None listed

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