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Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene

Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004288
Enrollment
Unknown
Registered
2021-01-19
Start date
2021-01-19
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 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 70 Years

Inclusion criteria

Inclusion criteria: 1 The normal group (1) Age between 18 and 70, gender is not limited; (2) Deny the history of rheumatoid arthritis and immune diseases; (3) No relevant history of serious, acute or chronic diseases; (4) Informed consent, voluntary subjects. 2 Untreated group (1) It conforms to the Western medical diagnostic criteria of RA and the Chinese medical diagnostic criteria of Fengcold-dampness-Bi syndrome; (2) Age between 18 and 70, gender is not limited; (3) First diagnosis, no use of anti-RA drug therapy; (4) The disease was active, DAS28 > 2.6. 3 Treatment effective group (1) It conforms to the western medical diagnostic criteria of RA, the effective treatment criteria of ACR20 in 1995, and the traditional Chinese medical diagnostic criteria of Fengcold-dampness-Bi syndrome; (2) Age 18 ~ 70 years old, gender is not limited; (3) DMARDS-based drug treatment for more than half a year, no use of biological agents and hormones, the condition is in remission, does not affect the normal study and work, life can take care of themselves; (4) DAS28 2.6 or less; (5) Signed informed consent and volunteered to take the test. 4 refractory group (1) It conforms to the Western medical diagnostic criteria of RA and the Chinese medical diagnostic criteria of Fengcold-dampness-Bi syndrome; (2) Age 18 ~ 70 years old, gender is not limited; (3) Patients who have been regularly treated with 2 or more DMARDs for more than half a year and are still active, unable to study and work normally, even with difficulties in living by themselves; (4) DAS28 > 3.2; (5) Those whose symptoms do not meet ACR20 remission standard; (6) Signed informed consent and volunteered to take the test.

Exclusion criteria

Exclusion criteria: (1) Patients who do not use the medicine according to the regulations cannot cooperate; (2) Pregnant or lactating women; (3) People who are currently infected with bacteria or viruses, or who are mentally or legally disabled; People with allergies or allergies to drugs such as methotrexate; (4) patients participating in other clinical trials; (5) Patients with severe heart, liver and kidney dysfunction and accompanied by other malignant tumors; (6) Those who have used biological agents and hormones within the last 3 months.

Design outcomes

Primary

MeasureTime frame
TCM syndrome scores;MRNA and protein expression levels of p-glycoprotein;DAS28;Therapeutic Effect of TCM Diseases;Protein mRNA and protein expression levels in breast cancer;

Secondary

MeasureTime frame
Number of joint tenderness;Patients were assessed for overall disease status VAS score;Anti-cyclic citrullinate peptide antibody;Blood sedimentation;Rheumatoid factor;Joint swelling number;C-reactive protein;The overall disease status VAS score was assessed by the investigator;Patients were assessed by VAS scale of pain;

Countries

China

Contacts

Public ContactLi Zhaofu

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