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

Not Applicable

• Conditions: Ankylosing spondylitis

• Registration Number: ITMCTR2000003433
• Lead Sponsor: Jiangsu Province Hospital of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASAS20, 40;BASDAI;ASDAS;

Secondary Outcome Measures

Name	Time	Method
ESR;Metabolomic changes in serum;CRP;