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Study on the characteristics of dampness syndrome of rheumatoid arthritis recurrence and the regulation mechanism of traditional Chinese medicine

Study on the characteristics of dampness syndrome of rheumatoid arthritis recurrence and the regulation mechanism of traditional Chinese medicine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078311
Enrollment
Unknown
Registered
2023-12-05
Start date
2023-12-05
Completion date
Unknown
Last updated
2024-03-25

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:The patients received Huayu Qiangshen Tongbi optimization C decoction granules (3 bags each time, 2 times a day, oral) and Shenlingbaizhu powder capsules (3 capsules each time, 3 ti

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ? Patients with moderate to low disease activity according to DAS28-CRP score (2.6 < DAS28-CRP=5.1); ? aged from 18 to 70 years old; ? in accordance with the indications of biological agents adalimumab; ? If the subject is taking oral glucocorticoids, the dose must have been stabilized to a dose equivalent to less than 10mg of prednisone per day for at least 4 weeks before enrollment; If discontinued, oral glucocorticoids were discontinued at least 2 weeks before enrollment. ? the person who signed the informed consent form.

Exclusion criteria

Exclusion criteria: ?Pregnant, lactating women, or those planning to become pregnant during the study cycle; ?Combined with other AIDs history, such as systemic lupus erythematosus, vasculitis; ?Patients with severe primary diseases of respiratory system and circulatory system, which could not be controlled by conventional drugs; Patients with a history of severe infection, tuberculosis, hepatitis and other infectious diseases, lymphocytosis, hematopoietic system abnormalities, and tumors; Patients with severe water, electrolyte and acid-base balance disorders; Patients with primary or secondary immunodeficiency or hypersensitivity; Patients with severe mental illness. Or patients with one of the following clinical measures: alanine aminotransferase or aspartate aminotransferase elevations > 3 times the upper limit of normal; Increased creatinine > 1.5 times the upper limit of normal; HIV serological test was positive; Any one of the main indicators of blood routine test was lower than the lower limit of normal value; Or other laboratory abnormalities judged by the investigator to be inappropriate for participation in the trial; ?Patients who are known to be allergic to the drugs used in the study or those with related drug components; ?Those who are participating in other drug clinical trials or have participated in other clinical trials within 4 weeks; ?Use of Chinese medicine or Chinese patent medicine, local therapy (hormone external medicine, etc.) within 2 weeks; Patients treated with oral systemic therapy (methotrexate, sulfasalazine, azathioprine, hydroxychloroquine, iguratimod, cyclosporine, mycophenolate mofetil, tacrolimus, etc.) except leflunomide within 4 weeks; Leflunomide used within 12 weeks (although leflunomide would need to be stopped at least 4 weeks before starting study treatment if standard cholestyramine washout was received for 11 days); Treatment with 5 biological agents within the half-life (etanercept 17.5 days, infliximab 50 days, adalimumab 70 days, etc.); ?Patients who had received interferon therapy within 4 weeks before enrollment or were expected to need interferon therapy during the study; Persons who received a live vaccine within 2 weeks before enrollment or who required a live vaccine during the trial; ?Patients with active gastroduodenal ulcer or gastritis caused by long-term use of non-steroidal anti-inflammatory drugs; ?Patients deemed by the investigator to be ineligible for enrollment.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;

Secondary

MeasureTime frame
The interval between the first recurrence;DAS28-CRP;DFR;X-ray examination of the affected joint;Health Assessment Questionnaire, HAQ;CRP;RF;ESR;Anti-ccp TEST;Ultrasound examination of the affected joints was performed;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactHuang Runyue

Guangdong Provincial Hospital of Chinese Medicine

ryhuang@gzucm.edu.cn+86 158 8993 2190

Outcome results

None listed

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