Rheumatoid arthritis with secondary osteoporosis (due to Liver and Kidney Deficiency)
Conditions
Interventions
Juanbi Qianggu Formula group:Methotrexate 7.5 mg once weekly + Juanbi Qianggu Granules (*Psoraleae Fructus* 15g, *Drynariae Rhizoma* 15g, *Sinomenii Caulis* 7.5g, *Epimedii Folium* 10g, *Angelicae Sin
Control group:Methotrexate 10 mg once weekly + Iguratimod 25 mg twice daily
Sponsors
Shanghai Guanghua Integrative Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Meet the Western medicine diagnostic criteria for both RA and OP; 2) Meet the diagnostic criteria for Liver and Kidney Deficiency syndrome in traditional Chinese medicine; 3) No history of long-term use of drugs affecting bone metabolism; 4) No severe diseases of the heart, liver, kidney, or endocrine system; 5) Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide antibody (ACCP); 6) Serum ß-CTX level > 0.584 ng/mL; 7) DAS28 score between 2.6 and 3.2; 8) Traditional Chinese medicine syndrome score = 6; 9) Age between 18 and 80 years; 10) No history of allergy to traditional Chinese medicine and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Do not meet the diagnostic criteria for RA or OP in Western medicine; 2) Highly active disease or severe joint deformity (Class IV functional status); 3) Concomitant with other rheumatic diseases; 4) Other types of secondary osteoporosis or severe chronic diseases; 5) Acute or chronic infectious diseases; 6) Pregnant or lactating women; 7) Poor compliance or allergy to the study medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate of ß-C-terminal telopeptide of type I collagen; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Activity Score for 28 joints based on Erythrocyte Sedimentation Rate;Visual Analogue Scale; Sharp radiographic scoring method for rheumatoid arthritis; Health Assessment Questionnaire Disability Index;Bone mineral density (BMD);25-hydroxyvitamin D3;Osteoprotegerin;Procollagen type I N-terminal propeptide;Tartrate-resistant acid phosphatase 5b; | — |
Countries
China
Contacts
Public ContactXiao Lianbo
Shanghai Guanghua Integrative Medicine Hospital
Outcome results
None listed