PneumoconiosisPhase 2NCT07178184

Evaluating the Efficacy and Safety of Modified Qing-Zao-Jiu-Fei Decoction on Pneumoconiosis Patients

A Phase 2 study testing Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD) in people with Pneumoconiosis, run by Chinese University of Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Pneumoconiosis
What is being tested?: Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: No sites listed yet
Study dates: 1 Nov 2025to 30 Apr 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 20-85;
Patients with pneumoconiosis (Confirmed case of pneumoconiosis by Pneumoconiosis compensation fund board);
Agree to undergo blood test and willing to complete questionnaires and take medication as scheduled; and
Willing to provide written informed consent.

Who cannot join

Patient with the following Chinese medicine syndromes/patterns according to Chinese medicine theory: dampness, lung deficiency and coldness, or Yang deficiency according to Chinese medicine theory;
Patients receiving Chinese medicine in a regular pattern within the past 2 weeks;
Patients with chronic co-morbidities such as other fibrotic lung diseases in addition to pneumoconiosis and/or co-existing heart disease;
Patients with a medical history of malignancy within the past 5 years;
Patients with a medical history of any serious diseases such as severe kidney and liver impairments, autoimmune disease, thyroid disease, Hodgkin's disease, lymphoma and leukemia;
Patients with known severe cognitive and mental disorders;
Documented pregnancy or lactation; or
Patients allergic to the drug used in this study.

About this study

Official title: Evaluating the Efficacy and Safety of Modified Qing-Zao-Jiu-Fei Decoction on Pneumoconiosis Patients: A Randomized, Double-blinded, Placebo-Controlled Trial

This is a multicenter, randomized, double-blind, placebo-controlled study to investigate the beneficial efficacy and safety of Chinese medicine formula Modified Qing Zao Jiu Fei Decoction (MQZJFD) on pneumoconiosis patients. Participants will be randomized into one of the two groups (MQZJFD treatment group or placebo control group), and both undergo a consultation process by the Chinese Medicine practitioner (CMP). Eligible participants will be randomized and receive either MQZJFD granules or placebo granules for 16 weeks followed by post-treatment visits at week 20. The study will last for 20 weeks with a treatment period of 16 weeks plus a follow-up period of 4 weeks.

Conditions: Pneumoconiosis
Being tested: Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD), Placebo
Keywords: RCT, Chinese Medicine, Pneumoconiosis
Medical subject headings: Pneumoconiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)Drug
MQZJFD is the core formula in this clinical study and consists of the 11 following herbs: Mori Folium 9g, Plaster stone 9g, Trichosanthis Fructus 9g, Ophiopogyonis Radix 6g, Armeniacae Semen Amarum 6g, Fritillariae Thunbergii Bulbus 6g, Eriobotryae Folium 6g, Ginseng Radix et Rhizoma 3g, Semen Sesami Nigrum 3g, Asini Corii Colla 3g, Glycyrrhizae Radix et Rhizoma 3g.
The formula will be prepared with single concentrated herbal granules (1 g of single concentrated herbal granule equates to 5 g of original dry herbs, except for Ophiopogyonis Radix whose ratio will be that 1 g of single concentrated herbal granule equals to 3 g of original dry herb, and Asini Corii Colla whose ratio will be that 1 g of single concentrated herbal granule equals to 1 g of original dry herb). The herbal granules will be provided by a Good Manufacturing Practice (GMP)-accredited supplier.
PlaceboDrug
The placebo granules consists of an inert substance made of starch filler, silica coating, flavor and coloring. Its appearance is unidentifiable to the real intervention drug. The placebo granules is also manufactured under GMP standards. To ensure blinding, the MQZJFD granules and placebo granules will be indistinguishable in appearance, smell and flavor.

Study groups in NCT07178184
Study group	Role	What they receive
Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)	Experimental	A chinese medicine formular Receives: Drug: Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)
Placebo	Placebo comparator	Placebo control Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of 6-minute Walk Test (6MWT) at weeks 4, 8, 12, 16 and 20.
The 6MWT, developed by Balke in 1963, is one of the tests widely used to assess functional exercise capacity evaluated by measuring the distance walked during 6 min. The test is easy to administer and is better tolerated and more reflective of the activities of daily living than other walk tests. Most activities of daily life usually are performed at a submaximal level of exertion, so the 6MWT seems to better reflect the functional exercise level for daily physical activities. Accordingly, the 6MWT would be a good estimation tool for objective health and assessment in pneumoconiosis and the test will be carried out according to the standards of the American Thoracic Society . The 6MWT will be conducted by trained investigators or research assistants.
Measured: Baseline, weeks 4, 8, 12, 16 and 20.

Secondary outcomes (9)

Change of St. George's Respiratory Questionnaire - Hong Kong version (SGRQ-HK) at weeks 4, 8, 12, 16 and 20
SGRQ is a disease-specific instrument designed for, and commonly applied in, patients with chronic obstructive lung disease (COPD). The SGRQ has three components: (1) Symptom, measuring respiratory symptoms; (2) Activity, measuring impairment of mobility or physical activity, and (3) Impact, measuring the psychosocial impact of disease. It has a Chinese version validated in Hong Kong (the SGRQ-HK), which has been applied in two Hong Kong studies of pneumoconiosis.
Measured: Baseline, weeks 4, 8, 12, 16 and 20
Change of Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8, 12, 16 and 20
PSQI measures the quality and pattern of sleep in older adult by measuring seven domains in 19 questions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction over the last month. The scoring is 0-3 on a Likert scale.
Measured: Baseline, weeks 4, 8, 12, 16 and 20
Change of Hospital anxiety and depression scale (HADS) at weeks 4, 8, 12, 16 and 20
The HADS, developed by Zigmond and Snaith in 1983, is a 14-item self assessment questionnaire commonly used to measure the severity of anxiety and depression in individuals undergoing medical care. It is now widely used in clinical and research settings. Many studies conducted around the world have confirmed its validity in community and primary care medical practice. HADS is often used to evaluate the mental health of patients with physical or chronic illnesses. The HADS questionnaire has 7 questions for anxiety and 7 questions for depression, with a scale of 0-3. Higher scores indicate higher levels of anxiety or depression.
Measured: Baseline, weeks 4, 8, 12, 16 and 20
Change of COPD Assessment Test (CAT) at weeks 4, 8, 12, 16 and 20
The CAT is a tool used to assess the severity of symptoms in patients with COPD, it can also be used in patients with pneumoconiosis. It consists of eight questions to assess the severity of symptoms and effects of COPD in daily life. These questions relate to dyspnoea, cough, sputum retention, chest pain, sleep quality, energy levels, mobility and anxiety. Each problem is rated on a scale of 0 to 5, the higher the score the more severe the symptoms.
Measured: Baseline, weeks 4, 8, 12, 16 and 20
Change of Patient Global Impression of Change (PGIC) at weeks 4, 8, 12, 16, 20
Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".
Measured: Baseline, weeks 4, 8, 12, 16, 20
Frequency of patients suffering from colds after baseline
Measured: From baseline to week 20
Incidence of patient hospitalization during the trial
Measured: From baseline to week 20
Change of the measurement of the body weight of patients
Measured: From baseline to week 20
Adverse events related to study treatment
Measured: From baseline to week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202530 Apr 2027

First posted17 Sep 2025
Study start1 Nov 2025 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion30 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PneumoconiosisStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A multicenter, randomized, double-blind, placebo-controlled study to investigate the beneficial efficacy and safety of Modified Qing Zao Jiu Fei Decoction (MQZJFD) on pneumoconiosis patients will be carried out in two Integrative Medical Centres (Shatin and Wan Chai), CUHK (IMCs-SCM), the CUHK-Chinese Medicine Specialist Clinic cum Teaching and Research Centre (CUHK-CMSCTRC) at the School of Chinese Medicine, CUHK, and the Centre for Clinical Trials on Chinese Medicine (CCTCM), Institute of Chinese Medicine, CUHK. Participants will be randomized into one of the two groups (MQZJFD treatment group or placebo control group), and both undergo a consultation process by the Chinese Medicine practitioner (CMP). Eligible participants will be randomized and receive either MQZJFD granules or placebo granules for 16 weeks followed by post-treatment visits at week 20. The study will last for 20 weeks with a treatment period of 16 weeks plus a follow-up period of 4 weeks.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07178184
Sponsor's protocol ID: PCFB study
Status last verified: Sep 2025
First submitted: 9 Sep 2025
Last updated: 17 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pneumoconiosis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Efficacy and Safety of Modified Qing-Zao-Jiu-Fei Decoction on Pneumoconiosis Patients: A Randomized, Double-blinded, Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT07178184
Acronym / sponsor ID: PCFB study
Conditions: Pneumoconiosis
Keywords: RCT, Chinese Medicine, Pneumoconiosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 1 Nov 2025 (estimated)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 30 Apr 2027 (estimated)
First posted: 17 Sep 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: A multicenter, randomized, double-blind, placebo-controlled study to investigate the beneficial efficacy and safety of Modified Qing Zao Jiu Fei Decoction (MQZJFD) on pneumoconiosis patients will be carried out in two Integrative Medical Centres (Shatin and Wan Chai), CUHK (IMCs-SCM), the CUHK-Chinese Medicine Specialist Clinic cum Teaching and Research Centre (CUHK-CMSCTRC) at the School of Chinese Medicine, CUHK, and the Centre for Clinical Trials on Chinese Medicine (CCTCM), Institute of Chinese Medicine, CUHK. Participants will be randomized into one of the two groups (MQZJFD treatment group or placebo control group), and both undergo a consultation process by the Chinese Medicine practitioner (CMP). Eligible participants will be randomized and receive either MQZJFD granules or placebo granules for 16 weeks followed by post-treatment visits at week 20. The study will last for 20 weeks with a treatment period of 16 weeks plus a follow-up period of 4 weeks.

Arm	Type	Receives
Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)	Experimental	Drug: Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)A chinese medicine formular
Placebo	Placebo comparator	Drug: PlaceboPlacebo control

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Aged 20-85;
Patients with pneumoconiosis (Confirmed case of pneumoconiosis by Pneumoconiosis compensation fund board);
Agree to undergo blood test and willing to complete questionnaires and take medication as scheduled; and
Willing to provide written informed consent.

Key exclusion criteria (8 listed)

Patient with the following Chinese medicine syndromes/patterns according to Chinese medicine theory: dampness, lung deficiency and coldness, or Yang deficiency according to Chinese medicine theory;
Patients receiving Chinese medicine in a regular pattern within the past 2 weeks;
Patients with chronic co-morbidities such as other fibrotic lung diseases in addition to pneumoconiosis and/or co-existing heart disease;
Patients with a medical history of malignancy within the past 5 years;
Patients with a medical history of any serious diseases such as severe kidney and liver impairments, autoimmune disease, thyroid disease, Hodgkin's disease, lymphoma and leukemia;

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
Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)MQZJFD is the core formula in this clinical study and consists of the 11 following herbs: Mori Folium 9g, Plaster stone 9g, Trichosanthis Fructus 9g, Ophiopogyonis Radix 6g, Armeniacae Semen Amarum 6g, Fritillariae Thunbergii Bulbus 6g, Eriobotryae Folium 6g, Ginseng Radix et Rhizoma 3g, Semen Sesami Nigrum 3g, Asini Corii Colla 3g, Glycyrrhizae Radix et Rhizoma 3g. The formula will be prepared with single concentrated herbal granules (1 g of single concentrated herbal granule equates to 5 g of original dry herbs, except for Ophiopogyonis Radix whose ratio will be that 1 g of single concentrated herbal granule equals to 3 g of original dry herb, and Asini Corii Colla whose ratio will be that 1 g of single concentrated herbal granule equals to 1 g of original dry herb). The herbal granules will be provided by a Good Manufacturing Practice (GMP)-accredited supplier.	Drug	Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)
PlaceboThe placebo granules consists of an inert substance made of starch filler, silica coating, flavor and coloring. Its appearance is unidentifiable to the real intervention drug. The placebo granules is also manufactured under GMP standards. To ensure blinding, the MQZJFD granules and placebo granules will be indistinguishable in appearance, smell and flavor.	Drug	Placebo

Primary outcome

Change of 6-minute Walk Test (6MWT) at weeks 4, 8, 12, 16 and 20.
Time frame: Baseline, weeks 4, 8, 12, 16 and 20.
The 6MWT, developed by Balke in 1963, is one of the tests widely used to assess functional exercise capacity evaluated by measuring the distance walked during 6 min. The test is easy to administer and is better tolerated and more reflective of the activities of daily living than other walk tests. Most activities of daily life usually are performed at a submaximal level of exertion, so the 6MWT seems to better reflect the functional exercise level for daily physical activities. Accordingly, the 6MWT would be a good estimation tool for objective health and assessment in pneumoconiosis and the test will be carried out according to the standards of the American Thoracic Society . The 6MWT will be conducted by trained investigators or research assistants.

9 secondary outcomes

Change of St. George's Respiratory Questionnaire - Hong Kong version (SGRQ-HK) at weeks 4, 8, 12, 16 and 20
Time frame: Baseline, weeks 4, 8, 12, 16 and 20
Change of Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8, 12, 16 and 20
Time frame: Baseline, weeks 4, 8, 12, 16 and 20
Change of Hospital anxiety and depression scale (HADS) at weeks 4, 8, 12, 16 and 20
Time frame: Baseline, weeks 4, 8, 12, 16 and 20
Change of COPD Assessment Test (CAT) at weeks 4, 8, 12, 16 and 20
Time frame: Baseline, weeks 4, 8, 12, 16 and 20
Change of Patient Global Impression of Change (PGIC) at weeks 4, 8, 12, 16, 20
Time frame: Baseline, weeks 4, 8, 12, 16, 20
Frequency of patients suffering from colds after baseline
Time frame: From baseline to week 20
Incidence of patient hospitalization during the trial
Time frame: From baseline to week 20
Change of the measurement of the body weight of patients
Time frame: From baseline to week 20
Adverse events related to study treatment
Time frame: From baseline to week 20

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Pneumoconiosis

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Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid
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Enrolling by invitationObservational study
The Edinburgh Lung Fibrosis Molecular Endotyping (ELFMEN) Study
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD) in people with Pneumoconiosis, run by Chinese University of Hong Kong.

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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of 6-minute Walk Test (6MWT) at weeks 4, 8, 12, 16 and 20. (time frame: Baseline, weeks 4, 8, 12, 16 and 20.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07178184.

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 17 Sep 2025.