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

NCT07178184 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-17

No results posted yet for this study

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

Interventions

DRUG

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

Placebo

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-12-31
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178184 on ClinicalTrials.gov