TCM for Coal Worker's Pneumoconiosis

Henan University of Traditional Chinese Medicine

Status: Unknown

Conditions: Coal Worker's Pneumoconiosis

Treatments: Drug: Chinese medicine compound combined with symptomatic treatments; Drug: Chinese medicine compound placebo combined with symptomatic treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT04841200

TCM for CWP

Details and patient eligibility

About

This study aims to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of pneumoconiosis and to provide high-quality evidence for the prevention and treatment of pneumoconiosis.

Full description

Pneumoconiosis refers to a group of occupational lung diseases characterized by diffuse fibrosis of the lung tissue. It is caused mainly by long-term inhalation and deposition of mineral dust, with varying levels of pathogenicity, into the lungs during occupational activities. Currently, there are a lack of effective therpy options for pneumoconiosis. Traditional Chinese Medicine (TCM) present a favorable prospect in treating pneumoconiosis. But the quality of the research was low. This needs to be further investigated by well-designed RCT to demonstrate the effect of TCM for pneumoconiosis.

In this study, a multicenter, randomized, double-blind, parallel controlled trial was designed. Patients with coal worker's pneumoconiosis were randomly divided into treatment group and control group by central random distribution system. For the treatment group, which was given symptomatic treatments, patients were additionally given Chinese medicine compound based on TCM syndrome differentiation. For the control group, which was given symptomatic treatments, patients were additionally given Chinese medicine compound placebo based on TCM syndrome differentiation. The intervention course is 52 weeks.The Six-minute Walking Distance (6MWD) and the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score were taken as the primary outcomes, while the Modified British Medical Research Council Dyspnea Scale (mMRC) score, Pulmonary function, Clinical symptoms and signs questionnaire, the Hospital Anxiety and Depression Scale (HADS) score, and the Short Form 36 Health Survey Questionnaire (SF-36) score as the secondary outcomes, third-party data management and blind evaluation were adopted.

Enrollment: 222 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pneumoconiosis (coal workers' pneumoconiosis) patients aged 18 to 75 years;
2. Comply with TCM syndrome differentiation standards;
3. Sign informed consent forms.

Exclusion criteria

1. Patients who do not get rid of the dust;
2. Patients with active tuberculosis, idiopathic pulmonary fibrosis, asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases;
3. Acute exacerbations occurred within 1 month before selection;
4. Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, HF New York Heart Association classes III to IV, stroke, cerebral hemorrhage);
5. Patients with severe liver and kidney disease (liver cirrhosis, portal hypertension, dialysis, kidney transplantation);
6. Tumor patients undergoing resection, radiotherapy and chemotherapy within 5 years before selection;
7. Patients with activity difficulties caused by neuromuscular diseases;
8. Patients with severe arthritis;
9. Patients with severe peripheral vascular disease;
10. Pregnant and lactating women;
11. Patients with severe cognitive and mental disorders;
12. Clinical investigators who are participating in other interventions within 1 month before selection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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222 participants in 2 patient groups, including a placebo group

Chinese medicine compound combined with symptomatic treatments

Experimental group

Description:

Patients in this arm will receive Chinese medicine compound based on TCM syndrome differentiation in addition to symptomatic treatments.

Treatment:

Drug: Chinese medicine compound combined with symptomatic treatments

Chinese medicine compound placebod combined with symptomatic treatments

Placebo Comparator group

Description:

Patients in this arm will receive Chinese medicine compound placebo based on TCM syndrome differentiation in addition to symptomatic treatments.

Treatment:

Drug: Chinese medicine compound placebo combined with symptomatic treatments