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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100004644

Enrollment

Unknown

Registered

2021-01-07

Start date

2021-01-01

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

None listed

Interventions

The treatment group:Longmengshahousan, Methotrexate tablets and Leflunomide tablets

The control group:Longmengshahousan simulation agent, Methotrexate tablets and Leflunomide tablets

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Number of joint tenderness;VAS score for pain;Morning stiffness time;Joint swelling number;DAS28 score;Disease curative effect;Syndrome score;	—

Secondary

Measure	Time frame
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;	—

Countries

China

Contacts

Public ContactChen Yanlin

Yunnan Hospital of Traditional Chinese Medicine

ynkmpzj@126.com+86 18987887581

Outcome results