NCT04841200

TCM for Coal Worker's Pneumoconiosis

Effects of Chinese Medicine on Patients With Coal Worker's Pneumoconiosis: Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of pneumoconiosis and to provide high-quality evidence for the prevention and treatment of pneumoconiosis.

Detailed description

Pneumoconiosis refers to a group of occupational lung diseases characterized by diffuse fibrosis of the lung tissue. It is caused mainly by long-term inhalation and deposition of mineral dust, with varying levels of pathogenicity, into the lungs during occupational activities. Currently, there are a lack of effective therpy options for pneumoconiosis. Traditional Chinese Medicine (TCM) present a favorable prospect in treating pneumoconiosis. But the quality of the research was low. This needs to be further investigated by well-designed RCT to demonstrate the effect of TCM for pneumoconiosis. In this study, a multicenter, randomized, double-blind, parallel controlled trial was designed. Patients with coal worker's pneumoconiosis were randomly divided into treatment group and control group by central random distribution system. For the treatment group, which was given symptomatic treatments, patients were additionally given Chinese medicine compound based on TCM syndrome differentiation. For the control group, which was given symptomatic treatments, patients were additionally given Chinese medicine compound placebo based on TCM syndrome differentiation. The intervention course is 52 weeks.The Six-minute Walking Distance (6MWD) and the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score were taken as the primary outcomes, while the Modified British Medical Research Council Dyspnea Scale (mMRC) score, Pulmonary function, Clinical symptoms and signs questionnaire, the Hospital Anxiety and Depression Scale (HADS) score, and the Short Form 36 Health Survey Questionnaire (SF-36) score as the secondary outcomes, third-party data management and blind evaluation were adopted.

Conditions

• Coal Worker's Pneumoconiosis

Interventions

Type	Name	Description
DRUG	Chinese medicine compound combined with symptomatic treatments	All patients were given symptomatic treatment according to consensus of Chinese experts on pneumoconiosis treatment (2018). There are 3 Recipe for the 3 traditional Chinese syndrome. Yang Qing Chen Fei Granules for syndrome of yin deficiency and heat-dryness, Bao Jin Chen Fei Granules for syndrome of pulmonary qi deficiency, Jin Shui Chen Fei Granules syndrome of deficiency of pulmonary and renal qi All drugs were made into granules by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. Each type of granule will be given orally, twice a day, for 52 weeks.
DRUG	Chinese medicine compound placebo combined with symptomatic treatments	All patients were given symptomatic treatment according to consensus of Chinese experts on pneumoconiosis treatment (2018). There are 3 placebo Recipe for the 3 traditional Chinese syndrome. Yang Qing Chen Fei Granules placebo for syndrome of yin deficiency and heat-dryness, Bao Jin Chen Fei Granules placebo for syndrome of pulmonary qi deficiency, Jin Shui Chen Fei Granules placebo for syndrome of deficiency of pulmonary and renal qi All drugs were made into granules by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. The appearance, shape, color and packaging of Chinese medicine compound placebo are the same as those of drugs. Each type of granule will be given orally, twice a day, for 52 weeks.

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-10-15
• Completion: 2022-12-30
• First posted: 2021-04-12
• Last updated: 2021-04-12

Locations

1 site across 1 country: China