Skip to content

One-arm, single-center clinical study for Huayu-Qiangshen-Tongbi Decoction in the treatment of preclinical rheumatoid arthritis

One-arm, single-center clinical study for Huayu-Qiangshen-Tongbi Decoction in the treatment of preclinical rheumatoid arthritis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025482
Enrollment
Unknown
Registered
2019-08-28
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

rheumatoid arthritis

Interventions

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients with positive anti-CCP antibody or RF, no arthralgia or joint pain but no arthritis or synovitis, who did not meet the 2010 ACR/EULAR RA classification criteria; (2) No treatment with remission antirheumatic drugs (DMARDs) was received. (3) The age ranged from 18 to 65 years. (4) Written informed consent signed by the subject or his family member (guardian) to participate in the experiment.

Exclusion criteria

Exclusion criteria: Patients who meet or expect to meet any of the following criteria will not be allowed to participate in this study: (1) history of other autoimmune diseases, such as Sjogren's syndrome and systemic lupus erythematosus; acute or chronic infectious diseases, including hepatitis B or hepatitis C infection; past history of cancer; evidence of active, latent or improperly treated Mycobacterium tuberculosis infection; (2) Patients with severe cardiovascular, brain, lung, liver, kidney and hematopoietic diseases; (3) Pregnant women, lactating women or patients with known mental disorders; (4) Patients with hemoglobin level less than 90 g/L, white blood cell count less than 3.0 *10^9/L, or platelet count less than 100 *10^9/L; (5) Patients whose glomerular filtration rate is lower than 40 ml/min; (6) The level of aspartate aminotransferase or alanine aminotransferase was 1.5 times higher than the upper limit of normal range. (7) Patients with active gastroduodenal ulcer or gastritis caused by long-term use of NSAIDs; (8) Patients allergic to experimental drugs; (9) Screening patients who participated in other clinical trials within 4 weeks.

Design outcomes

Primary

MeasureTime frame
RF;CCP;MRI;

Secondary

MeasureTime frame
ESR;CRP;

Countries

China

Contacts

Public ContactHuang Runyue

Guangdong Provincial Hospital of Chinese Medicine

huangrunyue@foxmail.com+86 15889932190

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026