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The clinical efficacy of hydrogen combined with tetrandrine in the treatment of silicosis fibrosis

Observation on the clinical efficacy of hydrogen-oxygen aerosol inhalation in the treatment of pneumoconiosis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12356200
Enrollment
114
Registered
2025-09-23
Start date
2023-10-23
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Silicosis Respiratory

Interventions

We used blocking randomisation. Staff other than participants, care providers, outcome assessors, data analysts generated the random allocation sequence. Random numbers include 1 and 2.The patients we

Sponsors

Laizhou Chronic Disease Prevention and Treatment Hospital, Shandong Province
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 50 - 80 years old, gender not restricted 2. Diagnosed with stage II silicosis based on medical history and related examinations 3. Dust exposure = 5 years 4. Voluntary signing of the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with a history of tuberculosis or those in the active stage of tuberculosis 2. Pulmonary tumors 3. Severe chronic obstructive pulmonary disease (GOLD level 4) 4. Estimated glomerular filtration rate (eGFR) lower than 30 milliliters per minute 5. Child-Pugh B/C grade 6. Pregnant women

Design outcomes

Primary

MeasureTime frame
Diffusion Lung capacity for CO measured using pulmonary function testing equipment after 6 months treatment

Secondary

MeasureTime frame
1. Forced vital capacity measured using pulmonary function testing equipment after 3 and 6 months treatment 2. Forced expiratory volume in one second measured using pulmonary function testing equipment after 3 and 6 months treatment 3. Diffusion Lung capacity for CO measured using pulmonary function testing equipment after 3 months treatment 4. Modified Medical Research Council measured using questionnaire after 3 and 6 months treatment 5. COPD Assessment Test measured using questionnaire after 3 and 6 months treatment 6. Walking distance measured using 6 min walk experiment after 6 months treatment 7. Serum IL-6 level measured using ELISA after 3 and 6 months treatment

Countries

China

Contacts

Public ContactKang Xiao
cpuokkkkk@163.com+86 13770992028

Outcome results

None listed

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