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

NCT07178184 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PCFB study
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

RCT; Chinese Medicine; Pneumoconiosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline, weeks 4, 8, 12, 16 and 20

• Change of Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8, 12, 16 and 20

  Baseline, weeks 4, 8, 12, 16 and 20

• Change of Hospital anxiety and depression scale (HADS) at weeks 4, 8, 12, 16 and 20

  Baseline, weeks 4, 8, 12, 16 and 20

• Change of COPD Assessment Test (CAT) at weeks 4, 8, 12, 16 and 20

  Baseline, weeks 4, 8, 12, 16 and 20

• Change of Patient Global Impression of Change (PGIC) at weeks 4, 8, 12, 16, 20

  Baseline, weeks 4, 8, 12, 16, 20

Study Arms (2)

Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)

EXPERIMENTAL

A chinese medicine formular

Drug: Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)

Placebo

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

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.

Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD)

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Links

• Related Info

MeSH Terms

Conditions

Pneumoconiosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. XIAN Yanfang, Assistant professor, School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share