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

Phase 1

Recruiting

• Conditions: difficult-to-treat rheumatoid arthritis

• Registration Number: ITMCTR2100004302
• Lead Sponsor: Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified