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Effect of Yuping Fengguizhi Granules on intestinal flora in patients with RA (wind-cold-dampness Bi syndrome) exposed to hormones

Effect of Yuping Fengguizhi Granules on intestinal flora in patients with RA (wind-cold-dampness Bi syndrome) exposed to hormones

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071123
Enrollment
Unknown
Registered
2023-05-05
Start date
2023-05-10
Completion date
Unknown
Last updated
2023-06-04

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:Prednisone acetate,Methotrexate,Leflunomide,Yupingfeng cassia branch granules
Control group:Prednisone acetate,Leflunomide,Methotrexate

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) RA patients who meet the 1987 ACR rheumatoid arthritis classification standard and the traditional Chinese medicine standard for waiting diagnosis of cold and dampness arthralgia syndrome; (2) patients currently taking glucocorticoids (prednisone acetate tablets or equivalent dose of hormone, varying dose); (3)DAS28 score =2.6; (4) No gastrointestinal disease in the past 2 months, no antibiotics, gastrointestinal motility drugs or probiotics; (5) Men and women aged 18-65; (6) Volunteer to participate in the study and agree to enter the clinical study, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) A history of severe respiratory (including pulmonary interstitial fibrosis), blood circulation, digestive, endocrine, urinary system diseases and malignant tumors before the study; (2) Those who have taken antibiotics, probiotics and prebiotics in the past 2 months; (3) Patients with bleeding prone active gastrointestinal disease and recent history of surgery; (4) Infection that cannot be controlled by antibiotics, serious infection or opportunistic infection history 2 months before the trial; (5) pregnant and lactating women; (6) Patients participating in other clinical trials; (7) Allergic constitution (allergic to Chinese medicine prescriptions, hormones and other experimental drugs); (8) Mental patients.

Design outcomes

Primary

MeasureTime frame
Hormone reduction;DAS28 score;alpha diversity;beta diversity;relative abundance;

Secondary

MeasureTime frame
Erythrocyte sedimentation;C-reactive protein;Liver function;renal function;Blood routine;Urine routine;Stool routine;TCM syndrome score;adrenocorticotropin;cortisol;Pain VAS scores assessed by patients;

Countries

China

Contacts

Public ContactPeng Jiangyun

Yunnan Hospital of Traditional Chinese Medicine

Pengjiangyun@126.com+86 13099963399

Outcome results

None listed

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