TCM for Coal Worker's Pneumoconiosis

NCT ID: NCT04841200

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2022-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Chinese medicine compound combined with symptomatic treatments

Patients in this arm will receive Chinese medicine compound based on TCM syndrome differentiation in addition to symptomatic treatments.

Group Type: EXPERIMENTAL

Chinese medicine compound combined with symptomatic treatments

Intervention Type: DRUG

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.

Chinese medicine compound placebod combined with symptomatic treatments

Patients in this arm will receive Chinese medicine compound placebo based on TCM syndrome differentiation in addition to symptomatic treatments.

Group Type: PLACEBO_COMPARATOR

Chinese medicine compound placebo combined with symptomatic treatments

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Pneumoconiosis (coal workers' pneumoconiosis) patients aged 18 to 75 years;

2. Comply with TCM syndrome differentiation standards;

3. Sign informed consent forms.

Exclusion Criteria

1. Patients who do not get rid of the dust;

2. Patients with active tuberculosis, idiopathic pulmonary fibrosis, asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases;

3. Acute exacerbations occurred within 1 month before selection;

4. Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, HF New York Heart Association classes III to IV, stroke, cerebral hemorrhage);

5. Patients with severe liver and kidney disease (liver cirrhosis, portal hypertension, dialysis, kidney transplantation);

6. Tumor patients undergoing resection, radiotherapy and chemotherapy within 5 years before selection;

7. Patients with activity difficulties caused by neuromuscular diseases;

8. Patients with severe arthritis;

9. Patients with severe peripheral vascular disease;

10. Pregnant and lactating women;

11. Patients with severe cognitive and mental disorders;

12. Clinical investigators who are participating in other interventions within 1 month before selection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian-sheng Li, Professor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Locations

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hulei Zhao, Ph.D.

Role: CONTACT

hulei890421@163.com

0371-66248624

Jiansheng Li, Professor

Role: CONTACT

li_ji8@163.com

0371-66248624

Facility Contacts

Hulei Zhao, Ph.D.

Role: primary

Other Identifiers

TCM for CWP

Identifier Type: -

Identifier Source: org_study_id