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Not yet recruiting NCT07178184

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

Phase II Interventional Pneumoconiosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified Qing-Zao-Jiu-Fei Decoction (MQZJFD), Placebo.
Who it may be relevant to
Registry conditions: Pneumoconiosis. Basic parameters: 20 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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
  • 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07178184 · PCFB study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗