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Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene

Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042440
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-01-21
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

difficult-to-treat 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. Normal group (1)Age 18 ~ 70 years, gender is not limited; (2)denial of history of rheumatoid arthritis and history of immune diseases; (3)no relevant history of severe acute and chronic diseases; (4)informed consent, voluntary test. 2. The initial untreated group (1)In line with the diagnostic criteria of RA Western medicine, and damp-heat obstruction syndrome of TCM diagnostic criteria; (2)aged 18-70 years, gender; (3)initial diagnosis without anti-RA drug treatment; (4)the disease was active, DAS28 > 2.6. 3. Effective treatment group (1)In line with RA western medicine diagnostic criteria, 1995 ACR20 treatment effective standard, and damp-heat obstruction syndrome of TCM diagnostic criteria; (2)aged 18 – 70 years, gender unlimited; (3)patients who were treated with DMARDs for more than half a year without using biological agents and hormones, were in remission, did not affect normal learning and work, and could take care of themselves; (4)DAS28 3.2; (5)patients whose symptoms did not meet the ACR20 remission standard; (6)sign informed consent, voluntary 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
MRNA and protein expression levels of p-glycoprotein;Protein mRNA anssion levels in breast cancer;DAS28;Rheumatoid factor;Anti-cyclic citrullinate peptide antibody;C-reactive protein;Blood sedimentation;Number of joint tenderness;Joint swelling number;Therapeutic Effect of TCM Diseases;TCM syndrome scores;Patients were assessed by VAS scale of pain;Patients were assessed for overall disease status VAS score;The overall disease status VAS score was assessed by the investigator;

Countries

China

Contacts

Public ContactLi Zhaofu

Medical Ethics Committee of 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: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026