The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003729

Enrollment

Unknown

Registered

2020-08-26

Start date

2020-10-01

Completion date

Unknown

Last updated

2023-02-20

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:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day

control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day

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. The dosage of corticosteroids was stable for at least 30 days before entering the trial, and remained unchanged in the following treatment. Patients receiving other DMARDs had to discontinue other DMARDs for more than 30 days; 4. At least 30 days before entering the trial, no NSAIDs were taken; 5. Sign the informed consent to enter the clinical study.

Exclusion criteria

Exclusion criteria: 1. Patients with pulmonary interstitial disease and elevated liver enzymes (ALT > 2 times normal value); 2. Pregnant and lactating women or patients who are ready to give birth in the near future; 3. Allergy to the test drug or allergic constitution; 4. Severe primary diseases, such as heart, liver, kidney, brain, endocrine system and hematopoietic system, were complicated; 5. Overlap other rheumatic diseases, such as systemic lupus erythematosus, Sjogren's syndrome, myositis, etc.

Design outcomes

Primary

Measure	Time frame
DAS28;Erythrocyte sedimentation rate;VAS test;Musculoskeletal ultrasound (synovitis);Musculoskeletal ultrasound (synovitis of tendon sheath);Musculoskeletal ultrasound (bone erosion);C-reactive protein;	—

Secondary

Measure	Time frame
VEGF;CX3CL1;MMP-9;TCM syndrome curative effect score;HAQ Disability Index, HAQ-DI;TNF-a;Joint tenderness count;Joint swelling count;iNOS;	—

Countries

China

Contacts

Public ContactHe Yikun

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

hhyykk@126.com+86 18917565332

Outcome results

None listed

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