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Prospective randomized controlled clinical study on efficacy and safety of Shenmai Huatan Granules in treating pneumoconiosis

Prospective randomized controlled clinical study on efficacy and safety of Shenmai Huatan Granules in treating pneumoconiosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086781
Enrollment
Unknown
Registered
2024-07-10
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Pneumoconiosis

Interventions

Control group:Basic treatment plus placebo.
Experimental Group:Basic treatment + Shenmaihuatan granules

Sponsors

The Second Affiliated Hospital of Shandong University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Pneumoconiosis patients meeting the diagnostic criteria of GBZ 70-2015 "Diagnosis of Occupational Pneumoconiosis"; (2) FEV1 16; (4) Pneumoconiosis diagnosed by traditional Chinese medicine was of the type of "deficiency of both qi and Yin, obstruction of lung by phlegm and blood stasis" (5) Stable stage of pneumoconiosis, finger pulse oxygen saturation >90%; (6) The age range was 45-75 years old (7) no more than two or more than the respiratory system disease complications; (8) Symptomatic treatment of chronic diseases (hypertension, diabetes, coronary heart disease, etc.) did not affect the trial results; (9) The subjects voluntarily participated in this study and signed the informed consent. (10) able and willing to comply with all trial requirements.

Exclusion criteria

Exclusion criteria: (1) happen organic disease in patients with liver, kidney and other organs; (2) allergic to traditional Chinese medicine; (3) continue to work in the dust exposure of patients; (4) patients contraindications to lung function examination; (5) within 4 weeks before screening merge infection or patients with high fever, including but not limited to respiratory virus infection, pulmonary fungal disease, acute bronchitis, pneumonia, sinusitis, urinary tract infection, cellulitis; (6) half a year operation history; (7) with cognitive impairment, severe acute or chronic psychiatric disorders, anxiety, depression, or related to the previous medical history; (8) 3 months has received or is being treated for a may affect the clinical results of the test; (9) any merger may be harming participants due to participate in the test or may affect the results of other diseases.

Design outcomes

Primary

MeasureTime frame
Forced expiratory flow in 1 second;

Secondary

MeasureTime frame
Forced vital capacity;Quality-of-life SCORES;The six-minute walk test;St George's Respiratory Questionnaire;

Countries

China

Contacts

Public ContactYan Rongdi

The Second Affiliated Hospital of Shandong University of Chinese Medicine

kellycat813@163.com+86 189 5319 2556

Outcome results

None listed

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