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Clinical study on the treatment of advanced rheumatoid arthritis (Phlegm stasis bi syndrome) by Soufeng Sanjie fomula for inhibiting bone erosion

medicine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006853
Enrollment
Unknown
Registered
2022-12-06
Start date
2022-12-14
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Rheumatoid arthritis

Interventions

Observation group:MTX+Traditional Chinese medicine (TCM)

Sponsors

Jiangsu Integrated Traditional Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of RA and the syndrome differentiation criteria of TCM bi syndrome (phlegm and blood stasis bi); (2) The age ranged from 18 to 65; (3) Did not receive slow-acting anti-rheumatism drugs within 3 months before the study began; (4) No non-steroidal anti-inflammatory drugs, hormones or other drugs were taken within 2 weeks before the study; (5) Sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) Lung interstitial disease; (2) With other connective tissue diseases; (3) Liver and kidney dysfunction (AST/ALT and SCr exceeding the normal upper limit); (4) Uncontrolled hypertension grade 2 and above; (5) Uncontrolled diabetes, or combined with diabetic target organ damage; (6) Previous history of gastrointestinal ulcer; Combined with serious cardiovascular and cerebrovascular diseases, blood, malignant tumors and other serious diseases; (8) Chronic infectious diseases, including hepatitis, tuberculosis, etc. (9) Patients who are participating in other clinical studies; (10) Male patients with fertility plans within six months, female patients with fertility plans, and patients during pregnancy and lactation; Suspected or proven history of alcohol or drug abuse or, in the investigator's judgment, likely to reduce or complicate enrollment

Design outcomes

Primary

MeasureTime frame
Number of swelling;Joint tenderness;TCM syndrome score;Morning stiffness time;Visual analog pain scale score (VAS score);Inflammatory cytokines ;

Countries

China

Contacts

Public ContactHuchunping
njhcp66@126.com13951685111

Outcome results

None listed

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