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Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome)

Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004239
Enrollment
Unknown
Registered
2021-01-09
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-20

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 Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. According to the ACR rheumatoid arthritis diagnostic criteria of 1987 and TCM diagnostic criteria of wind cold dampness syndrome; 2. Patients with RA disease activity whose DAS28 score is greater than 2.6; 3. Patients who had taken glucocorticoids (prednisone acetate tablets >= 20mg/d or equivalent dose if DAS28 score >= 5.1; Prednisone Acetate Tablets >= 10mg/d or equivalent dose if DAS28 score < 5.1); 4. Aged from 18 to 65 years, male or female; 5. Those who voluntarily participate in the trial and agree to enter the clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. There was a history of severe respiratory (including pulmonary interstitial fibrosis), blood circulation disorder, digestive, endocrine, urinary system diseases and malignant tumor before the trial; 2. Patients with bleeding tendency, active gastrointestinal disease and recent history of surgery; 3. There was infection that could not be controlled by antibiotics, and there was a history of severe infection or opportunistic infection 2 months before the trial; 4. Biological agents have been used in recent one month; 5. Pregnant and lactating women; 6. Patients participating in other clinical trials; 7. Allergic constitution (allergic to traditional Chinese medicine, hormone and other experimental drugs); 8. Mental patients; 9. Suspected or true history of alcohol or drug abuse, or other diseases that reduce or complicate the possibility of enrollment, such as frequent changes in working environment, are likely to cause loss of follow-up.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Public ContactWu Yang

Yunnan University of Traditional Chinese Medicine

wy13187705354@126.com+86 13187705354

Outcome results

None listed

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