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Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis

Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009029
Enrollment
Unknown
Registered
2016-08-15
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Rheumatoid arthritis

Interventions

RA:the experimental group:MTX 10-15mg po qw+BiQi Capsule, 1.2g po bid
RA:the control group:MTX 10-15mg po qw+LEF, 10mg, po, bid
OA:The traditional Chinese group:BiQi Capsule, 1.2g po bid+Celecoxib capsules 0.2g po take as needed
OA:The western medicine control group:Calcitriol Soft Capsules 0.25ug, po, bid+Celecoxib capsules 0.2g po take as needed

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. RA is confirmed by 2009 ACR Criteria; Imaging results suggest Class I, II or III disease (according to the 1987 American Rheumatism Association (ARA) classification standard); CM inclusion criteria: according to the syndrome of wind and damp stagnation syndrome, or cold and damp stagnation, or phlegm and stasis stagnation, or deficiency of Qi and Blood; 2. Patients aged between 18 and 65 years; 3. Volunteered for the research and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Imaging results suggest Class IV disease (according to the ARA classification standard); 2. Used in the last month or using glucocorticoids, MTX, hydroxychloroquine, willow nitrogen sulfanilamide pyridine, cyclophosphamide, penicillamine and gold preparations and other immunosuppressive drugs or slow-acting drugs; 3. Participating in another clinical trial; 4. Researchers of this study; 5. Unwilling to comply with treatment or assessment regimen; 6. Unable to comply with treatment or assessment regimen; 7. Severe extra-articular diseases like renal amyloidosis, constrictive pericarditis and so on; 8. Severe comorbid conditions likely to compromise follow up evaluation; 9. Complicated with active gastrointestinal diseases or diagnosed with esophagus or digestive ulcer in the last month; 10. Women currently pregnant, or who are planning on becoming pregnant during the study period; 11. Patients with mental disease; 12. Not suitable to enter this research in the view of the researchers.

Design outcomes

Primary

MeasureTime frame
Modified Sharp-van der Heijde;ACR20;Erythrocyte Sedimentation Rate;C Reactive Protein;DAS28;Blood Routine Test;Nrine Routine Test;Feces Rountine Test;ALT;BUN;Rheumatoid Factor;Matrix metalloproteinase 3;Osteoprotegerin;Receptor Activator for Nuclear Factor-? B Ligand;Digital Radiography with both hands;Electrocardiogram;Bone Mineral Density;Chest Digital Radiography;

Countries

China

Contacts

Public ContactQingchun Huang

Guangdong Provincial Hospital of Chinese Medicine

qch1963@163.com+86 13922230939

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026