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Clinical study of Hanbi ointment in the treatment of rheumatoid arthritis

Clinical study of Hanbi ointment in the treatment of rheumatoid arthritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041819
Enrollment
Unknown
Registered
2021-01-06
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Sponsors

The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients meeting the ACR / EULAR diagnostic criteria for RA in 2010; 2. Patients who meet the diagnostic criteria of traditional Chinese medicine syndromes of Bi cold dampness obstruction syndrome; 3. Subjects aged between 18 and 70 years, regardless of gender; 4. For the subjects whose X-ray staging of the joints of both hands belongs to stage I and II, the joint function classification belongs to grade I, II and III; 5. 2.6 < DAS28 < 5.1; 6. Subjects with at least pain or swelling in both wrists; 7. Patients who use hormones, hormone suspects or biological agents need to stop taking drugs for more than 3 months; 8. Patients who did not use NSAIDs or topical analgesics at least one week before enrollment. 9. Voluntary patients, signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe osteoarthritis, etc; 2. Patients with serious diseases such as cardiovascular, lung, liver, gastrointestinal tract, kidney, hematopoietic system or tumor, or complicated with various acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.); 3. Subjects with local skin damage, infection or injury of the joints; 4. Those patients who have no response to methotrexate and leflunomide; 5. Patients with contraindications (pulmonary fibrosis, etc.) and allergic history of experimental drugs; 6. Patients with history of alcohol abuse, drug abuse or neuropsychiatric disorders (epilepsy, depression, etc.); 7. Pregnant or lactating women have a family planning in the near future; 8. Patients who are participating in clinical research of other drugs.

Design outcomes

Primary

MeasureTime frame
TCM syndrome score;VAS score of pain degree;Number of joint swelling;Number of joint tenderness;Morning stiffness time;

Secondary

MeasureTime frame
Clinical outcome report Pro scale score;Classification of joint function;grip;Semi quantitative score of wrist grip strength by ultrasound;Erythrocyte sedimentation rate (ESR);C-reactive protein;Rheumatoid factor typing;Anti cyclic citrullinated peptide antibody;

Countries

China

Contacts

Public ContactPu Yongbin

The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine

75173427@qq.com+86 13987190559

Outcome results

None listed

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