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Clinical study on the changes of intestinal flora before and after Cold Syndrome (Wind-Cold-Dampness-Bi Syndrome) treated by Wenyang Yishen Tongluo Prescription

Clinical study on the changes of intestinal flora before and after Cold Syndrome (Wind-Cold-Dampness-Bi Syndrome) treated by Wenyang Yishen Tongluo Prescription

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041816
Enrollment
Unknown
Registered
2021-01-06
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-30

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 Provincial 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. Subjects meeting the diagnostic criteria of Western medicine; 2. Patients with RA of wind cold dampness syndrome in accordance with the diagnostic criteria of traditional Chinese medicine; 3. Subjects aged between 18 and 65 years, regardless of gender; 4. Subjects with X-ray stage I or II; joint function grade I, II, III; 5. Subjects with DAS28 score < 4.8; 6. The subjects who are willing to cooperate with the observation and have been followed up for more than 12 weeks can voluntarily cooperate with the implementation of questionnaire survey, routine examination and treatment plan, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe osteoarthritis, etc; 2. Subjects with infectious diarrhea within one month; 3. Subjects who had taken antibiotics within one month; 4. Subjects with cardiovascular, pulmonary (pulmonary interstitial fibrosis), liver, gastrointestinal tract, kidney, hematopoietic system or tumor and other serious diseases, or complicated with various acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.); 5. Subjects with contraindications and allergic history of experimental drugs; 6. Subjects with history of alcohol abuse, drug abuse or neuropsychiatric disorders (epilepsy, depression, etc.); 7. Pregnant or lactating women have a family planning in the near future; 8. Subjects who are participating in clinical research of other drugs.

Design outcomes

Primary

MeasureTime frame
Rheumatoid factor;Anti-CCP antibodies;C-reactive protein;Blood sedimentation;Number of joint tenderness;Joint swelling number;DAS28 score;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;

Countries

China

Contacts

Public ContactLi Zhaofu

Yunnan Provincial Hospital of Traditional Chinese medicine / the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

lzf0817@126.com+86 13187442840

Outcome results

None listed

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