Coal Worker's PneumoconiosisNCT04841200
TCM for Coal Worker's Pneumoconiosis
A study testing Chinese medicine compound combined with symptomatic treatments in people with Coal Worker's Pneumoconiosis, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coal Worker's Pneumoconiosis
- What is being tested?
- Chinese medicine compound combined with symptomatic treatments
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pneumoconiosis (coal workers' pneumoconiosis) patients aged 18 to 75 years;
- Comply with TCM syndrome differentiation standards;
- Sign informed consent forms.
Who cannot join
- Patients who do not get rid of the dust;
- Patients with active tuberculosis, idiopathic pulmonary fibrosis, asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases;
- Acute exacerbations occurred within 1 month before selection;
- 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);
- Patients with severe liver and kidney disease (liver cirrhosis, portal hypertension, dialysis, kidney transplantation);
- Tumor patients undergoing resection, radiotherapy and chemotherapy within 5 years before selection;
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- Patients with activity difficulties caused by neuromuscular diseases;
- Patients with severe arthritis;
- Patients with severe peripheral vascular disease;
- Pregnant and lactating women;
- Patients with severe cognitive and mental disorders;
- Clinical investigators who are participating in other interventions within 1 month before selection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Hulei Zhao, Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coal Worker's Pneumoconiosis
- Being tested
- Chinese medicine compound combined with symptomatic treatments, Chinese medicine compound placebo combined with symptomatic treatments
- Keywords
- Coal Worker's Pneumoconiosis, RCT, TCM
- Medical subject headings
- Anthracosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese medicine compound combined with symptomatic treatmentsDrug
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.
Chinese medicine compound placebo combined with symptomatic treatmentsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chinese medicine compound combined with symptomatic treatments | Experimental | Patients in this arm will receive Chinese medicine compound based on TCM syndrome differentiation in addition to symptomatic treatments. Receives: Drug: Chinese medicine compound combined with symptomatic treatments |
| Chinese medicine compound placebod combined with symptomatic treatments | Placebo comparator | Patients in this arm will receive Chinese medicine compound placebo based on TCM syndrome differentiation in addition to symptomatic treatments. Receives: Drug: Chinese medicine compound placebo combined with symptomatic treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from baseline 6MWD at week 13, 26, 39, and 52.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Change from baseline HADS scores at week 13, 26, 39, and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start15 Apr 2021 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coal Worker's PneumoconiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian-sheng Li, Professor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841200
- Sponsor's protocol ID
- TCM for CWP
- Status last verified
- Dec 2020
- First submitted
- 5 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chinese Medicine on Patients With Coal Worker's Pneumoconiosis: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04841200
- Acronym / sponsor ID
- TCM for CWP
- Conditions
- Coal Worker's Pneumoconiosis
- Keywords
- Coal Worker's Pneumoconiosis, RCT, TCM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese medicine compound combined with symptomatic treatments | Experimental | Drug: Chinese medicine compound combined with symptomatic treatmentsPatients in this arm will receive Chinese medicine compound based on TCM syndrome differentiation in addition to symptomatic treatments. |
| Chinese medicine compound placebod combined with symptomatic treatments | Placebo comparator | Drug: Chinese medicine compound placebo combined with symptomatic treatmentsPatients in this arm will receive Chinese medicine compound placebo based on TCM syndrome differentiation in addition to symptomatic treatments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pneumoconiosis (coal workers' pneumoconiosis) patients aged 18 to 75 years;
- Comply with TCM syndrome differentiation standards;
- Sign informed consent forms.
Key exclusion criteria (12 listed)
- Patients who do not get rid of the dust;
- Patients with active tuberculosis, idiopathic pulmonary fibrosis, asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases;
- Acute exacerbations occurred within 1 month before selection;
- 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);
- Patients with severe liver and kidney disease (liver cirrhosis, portal hypertension, dialysis, kidney transplantation);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese medicine compound combined with symptomatic treatmentsAll 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. | Drug | Chinese medicine compound combined with symptomatic treatments |
| Chinese medicine compound placebo combined with symptomatic treatmentsAll 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. | Drug | Chinese medicine compound placebod combined with symptomatic treatments |
Primary outcome
COPD assessment test (CAT)
Time frame: Change from baseline CAT scores at week 13, 26, 39, and 52.
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).
Six-minute walk distance (6MWD)
Time frame: Change from baseline 6MWD at week 13, 26, 39, and 52.
Six-minute walk distance (6MWD) will be conducted to assess exercise capacity.
5 secondary outcomes
modified Medical Research Council (mMRC)
Time frame: Change from baseline mMRC scores at week 13, 26, 39, and 52.
Pulmonary Function
Time frame: 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
Time frame: 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)
Time frame: Change from baseline SF-36 scores at week 13, 26, 39, and 52.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline HADS scores at week 13, 26, 39, and 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-sheng Li, Professor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese medicine compound combined with symptomatic treatments in people with Coal Worker's Pneumoconiosis, run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hulei Zhao, Ph.D. (0371-66248624, hulei890421@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD assessment test (CAT) (time frame: Change from baseline CAT scores at week 13, 26, 39, and 52.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.