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

The Chinese University of Hong Kong

Status and phase: Not yet enrolling; Phase 2

Conditions: Pneumoconiosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07178184

PCFB study

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Exclusion criteria

1. 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;
2. Patients receiving Chinese medicine in a regular pattern within the past 2 weeks;
3. Patients with chronic co-morbidities such as other fibrotic lung diseases in addition to pneumoconiosis and/or co-existing heart disease;
4. Patients with a medical history of malignancy within the past 5 years;
5. 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;
6. Patients with known severe cognitive and mental disorders;
7. Documented pregnancy or lactation; or
8. Patients allergic to the drug used in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

A chinese medicine formular

Treatment:

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

Placebo

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: Placebo