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Randomized controlled trial of Zhuanbing Fang combined with Shenling Baizhu Powder in the treatment of rheumatoid arthritis due to spleen deficiency and dampness

Randomized controlled trial of Zhuanbing Fang combined with Shenling Baizhu Powder in the treatment of rheumatoid arthritis due to spleen deficiency and dampness

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053894
Enrollment
Unknown
Registered
2021-12-02
Start date
2021-11-29
Completion date
Unknown
Last updated
2022-10-31

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:Combined with Shenling Baizhu Powder

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The research subjects should meet the following diagnostic criteria: (1) Western medicine diagnostic criteria: the RA classification criteria of the 2010 ACR/EULAR were used for comprehensive judgment; (2) The diagnostic criteria of TCM syndromes refer to the ''Diagnostic Criteria for Syndrome of Rheumatoid Arthritis with Spleen Deficiency and Damp Resistance Syndrome'' (T/CACM1347-2021) issued by the National Chinese Medicine Association in 2021; 2. According to DAS28-CRP score, patients with low disease activity (2.6 <= DAS28-CRP <= 3.2); 3. Aged between 18 and 70 years; 4. Have not received disease-modifying antirheumatic drugs (DMARDs) treatment, or have received DMARD drug treatment in the past, but have not used such drugs for at least the past month; 5. Written informed consent signed by the subjects or their family members (guardians) to participate in this trial.

Exclusion criteria

Exclusion criteria: 1. Combined history of other autoimmune diseases, such as Sj?gren's syndrome, systemic lupus erythematosus, etc.; suffering from acute or chronic infectious diseases, including hepatitis B or hepatitis C infection; past history of cancer; evidence of active, latent, or poorly treated Mycobacterium tuberculosis infection; 2. Patients with severe cardiovascular, brain, lung, liver, kidney and hematopoietic diseases; 3. Pregnant patients, lactating patients or patients with known mental disorders; 4. The hemoglobin level is less than 90 g/L, the white blood cell count is less than 3.0x10^9 per liter, or the platelet count is less than 100x10^9 per liter; 5. Patients with glomerular filtration rate less than 40ml/min; 6. The level of aspartate aminotransferase or alanine aminotransferase is 1.5 times higher than the upper limit of the normal range; 7. Patients with active gastroduodenal ulcer or gastritis caused by long-term use of non-steroidal anti-inflammatory drugs; 8. Patients who are allergic to test drugs; 9. Screen patients who participate in other clinical trials within 4 weeks.

Design outcomes

Primary

MeasureTime frame
28 Joint Disease Activity Index-C-Reactive Protein Score;

Secondary

MeasureTime frame
Rheumatoid factor;Anti-cyclic citrullinated peptide antibody;ESR;C-reactive protein;ACR20 remission rate;Quality of life score;Joint symptoms and signs;Safety;9/5000 X-ray examination of the involved joint;

Countries

China

Contacts

Public ContactHuang Runyue
ryhuang@gzucm.edu.cn+86 15889932190

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 30, 2026