ITMCTR2100004302RecruitingPhase 1
Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene
Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 70 (—)
- Sex
- All
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 <= 2.6;
- •(5)Sign informed consent, voluntary test.
- •4. Refractory group
- •(1)In line with RA western medicine diagnostic criteria, as well as damp-heat obstruction syndrome of TCM diagnostic criteria;
- •(2)aged 18 – 70 years, gender unlimited;
- •(3)patients who received regular application of two or more DMARDs for more than half a year were ineffective, and the disease was still active, unable to study and work normally, or even had difficulties in self-care;
- •(4)DAS28 > 3.2;
- •(5)patients whose symptoms did not meet the ACR20 remission standard;
- •(6)sign informed consent, voluntary test.
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.
Investigators
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