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Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis

Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041777
Enrollment
Unknown
Registered
2021-01-05
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

rheumatoid arthritis

Interventions

Sponsors

Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. RA patients who met the 1987 ACR and Medium-to-medical syndrome criteria for diagnosis of cold and dampness syndrome; 2. RA activity subjects with DAS28 score >2.6; 3. Previous use of glucocorticoids (if DAS28 score >= 5.1, take prednisone acetate tablets >= 20mg/ day or equivalent dose of corticosteroids; For patients with 2.6 = 10mg/ day or equivalent dose of hormone); 4. Ages 18-65 years, male or female; 5. Those who voluntarily participate in this trial and agree to enter into the clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Had a history of severe respiratory (including pulmonary interstitial fibrosis), blood circulation, digestive, endocrine, urinary diseases and malignant tumors before taking part in the study; 2. Patients with bleeding tendency, active gastrointestinal diseases, and patients with recent surgical history; 3. There is an infection that cannot be controlled by antibiotics, and a history of severe infection or opportunistic infection 2 months before the study; 4. Use of biological agents in recent January; 5. Pregnant and lactating women; 6. Patients participating in other clinical trials; 7. People with allergic constitution (allergic to juanyi granules and hormones); 8. Persons with mental illness; 9. A history of alcohol and drug abuse is suspected or present, or other conditions that reduce the likelihood of inclusion or complicate inclusion, such as frequent changes in the work environment, are likely to cause loss of follow-up.

Design outcomes

Primary

MeasureTime frame
Joint swelling number;Number of joint tenderness;DAS28 score;Hormone withdrawal;

Secondary

MeasureTime frame
Curative effect of TCM diseases;TCM syndromes are equally divided;VAS score for the degree of pain assessed by the patient;The patient assessed the overall condition of the disease VAS score;The overall condition VAS score for the disease was assessed by the researchers;Health Assessment Questionnaire (HAQ);ACR20 standard than;cortisol;Corticotropin;Lymphocyte subsets;cytokines;Erythrocyte sedimentation rate;C-reactive protein;Hypersensitive C-reactive protein;

Countries

China

Contacts

Public ContactWang Yan

Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

wangyanfs@163.com+86 15912538996

Outcome results

None listed

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