TCM for Coal Worker's Pneumoconiosis

Effects of Chinese Medicine on Patients With Coal Worker's Pneumoconiosis: Study Protocol for a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Coal Worker's Pneumoconiosis
• Intervention / Treatment: Drug: Chinese medicine compound combined with symptomatic treatments; Drug: Chinese medicine compound placebo combined with symptomatic treatments

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.

• Study Type: Interventional
• Enrollment (Anticipated): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
      • Contact: Hulei Zhao, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese medicine compound combined with symptomatic treatments; Patients in this arm will receive Chinese medicine compound based on TCM syndrome differentiation in addition to symptomatic treatments.	Drug: Chinese medicine compound combined with symptomatic treatments; All patients were given symptomatic treatment according to consensus of Chinese experts on pneumoconiosis treatment (2018). There are 3 Recipe for the 3 traditional Chinese syndrome. Yang Qing Chen Fei Granules for syndrome of yin deficiency and heat-dryness, Bao Jin Chen Fei Granules for syndrome of pulmonary qi deficiency, Jin Shui Chen Fei Granules syndrome of deficiency of pulmonary and renal qi All drugs were made into granules by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. Each type of granule will be given orally, twice a day, for 52 weeks.
Placebo Comparator: Chinese medicine compound placebod combined with symptomatic treatments; Patients in this arm will receive Chinese medicine compound placebo based on TCM syndrome differentiation in addition to symptomatic treatments.	Drug: Chinese medicine compound placebo combined with symptomatic treatments; All patients were given symptomatic treatment according to consensus of Chinese experts on pneumoconiosis treatment (2018). There are 3 placebo Recipe for the 3 traditional Chinese syndrome. Yang Qing Chen Fei Granules placebo for syndrome of yin deficiency and heat-dryness, Bao Jin Chen Fei Granules placebo for syndrome of pulmonary qi deficiency, Jin Shui Chen Fei Granules placebo for syndrome of deficiency of pulmonary and renal qi All drugs were made into granules by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. The appearance, shape, color and packaging of Chinese medicine compound placebo are the same as those of drugs. Each type of granule will be given orally, twice a day, for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD assessment test (CAT)	The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).	Change from baseline CAT scores at week 13, 26, 39, and 52.
Six-minute walk distance (6MWD)	Six-minute walk distance (6MWD) will be conducted to assess exercise capacity.	Change from baseline 6MWD at week 13, 26, 39, and 52.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Medical Research Council (mMRC)	The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception.	Change from baseline mMRC scores at week 13, 26, 39, and 52.
Pulmonary Function	Pulmonary functions were measured with spirometric tests by experienced physical therapists.	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)]
Clinical Symptoms and Signs Questionnaire	Assessment will be performed by clinical symptoms and signs questionnaire. The clinical symptoms to be evaluated in this study include cough, expectoration, chest tightness, shortness of breath, wheezing and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.	Change from baseline clinical symptoms and signs questionnaire scores at week 13, 26, 39, and 52.
MOS 36-Item Short-Form Health Survey (SF-36)	The MOS 36-Item Short-Form Health Survey (SF-36) is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 items, divided into eight areas: functional capacity, physical aspects, pain, health general state, vitality, social aspects, emotional aspects, mental health and one question of comparative evaluation between current health conditions and the health conditions from the previous year. Scores range from 0 to 100 where zero corresponds to the "the worst health state" and 100, to "the best health state".	Change from baseline SF-36 scores at week 13, 26, 39, and 52.
Hospital Anxiety and Depression Scale (HADS)	Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.	Change from baseline HADS scores at week 13, 26, 39, and 52.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Investigators: Study Chair: Jian-sheng Li, Professor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2021
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: RCT; TCM; Coal Worker's Pneumoconiosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Lung Diseases, Interstitial; Lung Injury; Pneumoconiosis; Anthracosis
• Other Study ID Numbers: TCM for CWP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No