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Clinical observation on the treatment of joint swelling and pain due to the Fengtabuzu syndrome of RA by Dai medicine Longmengshahousa

Phase 1
Recruiting
Conditions
RA
Registration Number
ITMCTR2100004644
Lead Sponsor
Yunnan Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Meet the 2010 ACR/EULAR DIAGNOSTIC criteria for RA;
(2) It conforms to the diagnostic criteria of Fengtabuzu syndrome;
(3) Between the ages of 18 and 70, regardless of gender;
(4) the hands joint X-ray stage I and II, joint function class I and II, III;
(5) 2.6 < DAS28 < 5.1;
(6) Pain or swelling of at least two wrists;
(7) Patients who use hormones, hormone-suspected substances or biological agents need to stop taking drugs for more than 3 months;
(8) No non-steroidal anti-inflammatory drugs or topical analgesics were used at least 1 week before enrollment.
(9) Voluntary subjects signed informed consent.

Exclusion Criteria

(1) Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, and severe osteoarthritis;
(2) Complicated with cardiovascular, pulmonary, liver, gastrointestinal, kidney, hematopoietic system or tumor, or complicated with various acute or chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.);
(3) Local skin damage, infection or trauma of the tested joint is not healed;
(4) Those who did not respond to the treatment of methotrexate or leflunomide;
(5) A history of contraindications to experimental drugs (pulmonary interstitial fibrosis, etc.) and allergies;
(6) A history of alcoholism, drug addiction or neuropsychiatric disorders (epilepsy, depression, etc.);
(7) Pregnant or lactating women who have recently had family planning;
(8) Participating in other drug clinical studies.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of joint tenderness;VAS score for pain;Morning stiffness time;Joint swelling number;DAS28 score;Disease curative effect;Syndrome score;
Secondary Outcome Measures
NameTimeMethod
ACR20 standard than;Semi-quantitative ultrasonic score of grip strength and wrist joint;The overall condition VAS score for the disease was assessed by the researchers;CRP;Classification of joint function;Clinical outcome report PRO scale score;The patient assessed the overall condition of the disease VAS score;ESR;
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