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A prospective randomized controlled clinical study on the effect of Yiqi-Huayu-Tongbi Formula on cardiopulmonary function in rheumatoid arthritis and a mechanism based on oxidized lipidomics

A prospective randomized controlled clinical study on the effect of Yiqi-Huayu-Tongbi Formula on cardiopulmonary function in rheumatoid arthritis and a mechanism based on oxidized lipidomics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000969
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

rheumatoid arthritis

Interventions

experimental group:Yiqi-Huayu-Tongbi decoction combined with stable RA treatment of Western Medicine
control group:stable RA treatment of Western Medicine

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the 2010 ELAR/ACR RA diagnostic criteria; (2) Patients with the 10-year risk of cardiovascular disease < 10.0%; (3) Patients with 20 to 80 years of age; (4) Patients with stable RA treatment regimen before enrollment and the original treatment regimen was planned to be maintained during the study period; (5) Patients who sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with uncontrolled hypertension or systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg after being controlled by antihypertensive drugs; (2) Patients with the presence of left coronary artery main stenosis; (3) Patients with uncontrolled tachyarrhythmias high-grade or complete conduction block and causing symptoms or hemodynamic disorders; (4) Patients who are unable to accept the tolerable exercise test; (5) Patients with acute endocarditis; (6) Patients with obstructive hypertrophic cardiomyopathy; (7) Patients with symptomatic severe aortic stenosis decompensated heart failure acute pulmonary embolism deep vein thrombosis acute pericarditis or myocarditis acute aortic dissection; (8) Patients with chronic lung disease accompanied by dyspnea; (9) Patients with recent stroke or transient ischemic attack cognitive dysfunction; (10) Patients with serious clinical complications such as uncorrected infection severe anemia and electrolyte imbalance; (11) Patients with obvious abnormalities in liver and kidney function (alanine aminotransferase or aspartate aminotransferase or creatinine > 1.5 times the upper limit of the normal reference value); (12) Patients who are taking lipid-lowering drugs; (13) Patients who have participated in other clinical studies within the last one month; (14) Other conditions that the investigator considers unsuitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
Peak oxygen pulse;

Secondary

MeasureTime frame
blood lipids;Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire,BRAF-MDQ;erythrocyte sedimentation rate;C-reactive protein;arteriosclerotic cardiovascular disease risk ratio;Disease Activity Score 28;Lung function;Cardiac ultrasound;

Countries

China

Contacts

Public ContactHuang Qingchun

Guangdong Provincial Hospital of Chinese Medicine

qch1963@163.com13922230939

Outcome results

None listed

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