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Exploratory Randomized Controlled Clinical Trial for Chinese medicine treatment based on symptom differentiation for Pneumoconiosis

Exploratory Randomized Controlled Clinical Trial for Chinese medicine treatment based on symptom differentiation for Pneumoconiosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019515
Enrollment
Unknown
Registered
2018-11-15
Start date
2018-12-01
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumoconiosis

Interventions

Group 1:TCM therapy based on syndrome differentiation + standard western medicine therapy
Group 21:Chinese medicine placebo + standard western medicine therapy

Sponsors

The First Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with stable stage of pneumoconiosis (coal workers' pneumoconiosis); (2) Comply with TCM syndrome differentiation standards; (3) Aged between 18 and 75 years old; (4) Sign informed consent forms.

Exclusion criteria

Exclusion criteria: (1) Those who are not exposed to dust or receive alveolar lavage; (2) Patients with active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases; (3) Acute exacerbations occurred within 1 month prior to enrollment; (4) Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.); (5) Patients with severe liver and kidney disease (severe liver disease refers to hemorrhage of cirrhosis, portal hypertension and varicose veins, severe kidney disease including dialysis, kidney transplantation); (6) Tumor patients undergoing resection, radiotherapy and chemotherapy within 5 years; (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 one month prior to enrollment;

Design outcomes

Primary

MeasureTime frame
exercise capacity;quality of life;

Secondary

MeasureTime frame
severity of dyspnea;The number and degree of acute exacerbations;lung function;Other health-related quality of life;

Countries

China

Contacts

Public ContactLi Jiansheng

The First Hospital of He'nan University of Chinese Medicine

li_js8@163.com+86 0371 65676568

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026