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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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.

Первичные конечные точки

• Change of 6-minute Walk Test (6MWT) at weeks 4, 8, 12, 16 and 20. [Срок оценки: Baseline, weeks 4, 8, 12, 16 and 20.]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07178184 · PCFB study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗