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Efficacy and safety of Bushen Jiedu Tongluo Decoction in Active Rheumatoid Arthritis: study protocol for a Multi-center Randomized Double-Blind Controlled Trial

Efficacy and safety of Bushen Jiedu Tongluo Decoction in Active Rheumatoid Arthritis: study protocol for a Multi-center Randomized Double-Blind Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000194
Enrollment
Unknown
Registered
2025-01-26
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

rheumatoid arthritis

Interventions

Experimental group:Basic western medicine treatment plus Bushen Jiedu Tongluo Decoction Granule One dose a day two times a day
control group:Basic western medicine treatment plus placebo Granule One dose a day, two times a day

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria of RA it is in accordance with the diagnostic criteria of RA in active stage in accordance with the diagnostic criteria of traditional Chinese medicine; 2. Patients aged 18-80 years old; 3. Patients receiving hormone therapy should have a stable dosage of medication for at least 30 days before entering the trial and remain unchanged throughout subsequent treatments. Patients who receive other DMARDs must interrupt other DMARDs for at least 30 days; 4. Sign the informed consent form for entering clinical research.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the above inclusion criteria; 2. Pregnant lactating women or patients who are planning to give birth recently; 3. Individuals who are allergic to the experimental drug or have an allergic constitution; 4. Patients with severe primary diseases such as heart liver kidney brain endocrine system and hematopoietic system as well as psychiatric patients; 5. Patients with interstitial lung disease; Patients with severe elevation of liver enzymes (ALT = 3 times normal); Patients with renal dysfunction (eGFR<90ml/min/1.73m2); 6. Overlap with other rheumatic diseases such as systemic lupus erythematosus Sjogren's syndrome myositis etc.

Design outcomes

Primary

MeasureTime frame
DAS28-ESR;

Secondary

MeasureTime frame
ACR20/50/70 reaction standard;HIF-1a;RAPID3;Ultrasound Imaging Score(US7);MIF;SHARP Score;C-reactive protein;TCM syndrome curative effect score;Erythrocyte sedimentation rate;HAQ Disability Index, HAQ-DI;MMP-2;ICAM-1;VAS test;CD147;VCAM-1;

Countries

China

Contacts

Public ContactHe Yikun

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

hhyykk@126.com+86 189 1756 5332

Outcome results

None listed

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