Clinical trial NCT04841200: TCM for Coal Worker's Pneumoconiosis
Official title: Effects of Chinese Medicine on Patients With Coal Worker's Pneumoconiosis: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coal Worker's Pneumoconiosis
Keywords: Coal Worker's Pneumoconiosis
RCT
TCM
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: COPD assessment test (CAT)
timeFrame: Change from baseline CAT scores at week 13, 26, 39, and 52.
measure: Six-minute walk distance (6MWD)
timeFrame: Change from baseline 6MWD at week 13, 26, 39, and 52.
Secondary outcomes:
measure: modified Medical Research Council (mMRC)
timeFrame: Change from baseline mMRC scores at week 13, 26, 39, and 52.
measure: Pulmonary Function
timeFrame: Changes from baseline to week 26, and 52 in pulmonary function parameters [FEV1 (L),FVC (L),FEV1/FVC (%),FEV1%,PEF (L/sec),DLCO (mL/mmHg/min)]
measure: Clinical Symptoms and Signs Questionnaire
timeFrame: Change from baseline clinical symptoms and signs questionnaire scores at week 13, 26, 39, and 52.
measure: MOS 36-Item Short-Form Health Survey (SF-36)
timeFrame: Change from baseline SF-36 scores at week 13, 26, 39, and 52.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline HADS scores at week 13, 26, 39, and 52.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jian-sheng Li, Professor
role: STUDY_CHAIR
References: