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A multicenter, non-randomized, open, parallel controlled study of hydrogen inhalation in the intervention of pulmonary nodules

A multi-center, non-randomized, open, parallel controlled study of hydrogen inhalation in pulmonary nodules carries

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076152
Enrollment
Unknown
Registered
2023-09-26
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

pulmonary nodules

Interventions

control (non-hydrogen absorption) group:No measure
Intervention (hydrogen absorption) group
:Inhale hydrogen or a mixture of hydrogen and oxygen through the respiratory system

Sponsors

Jinan People's Hospital (Affiliated People's Hospital, Shandong First Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Carriers of pulmonary micronodules (with evidence of recent (less than 1 month) thin-slice CT diagnosis); 2) The diameter (long diameter) of pulmonary micronodules should be limited to 3-8mm; 3) Patients with micro/small pulmonary nodules between 8-10mm, who explicitly refuse clinical intervention; 4) The imaging size, shape, density, texture, marginal and internal characteristics of pulmonary micronodules, as well as clinical classification, are not affected, but need to be grouped evenly; 5) Age 35-80 years old, gender is not limited; The overlimit shall be appropriately expanded by the researcher according to the actual situation; 6) The physiological functions of the major organs of the body are basically normal, and the basic life is not affected; 7) The subject voluntarily agrees to participate in the observation and can cooperate closely in the intervention observation; 8) The subject himself or his legal representative agrees and signs the Informed Consent;

Exclusion criteria

Exclusion criteria: 1) Patients with an expected survival of less than 6 months; 2) Patients with cancer of any tissue or molecular type who have been diagnosed; 3) Highly suspected cancer patients with a diameter greater than 10mm; For those who strongly wish to join the group, the restrictions can be appropriately relaxed; 4) Carriers of pulmonary micronodules less than 3mm in length and diameter; For those who strongly wish to join the group, the restrictions can be appropriately relaxed; 5) Patients who do not regularly take antibacterial drugs and anti-inflammatory drugs; 6) Suspected or have a history of alcohol or drug abuse; 7) Carriers who are difficult to accurately evaluate the safety and effectiveness of hydrogen (or hydrogen and oxygen mixtures); 8) Hydrogen (or hydrogen and oxygen mixture) contraindications; 9) Patients who are bedridden for a long period of time (including, but not limited to, severe decline of various organs) 10) patients who are not considered appropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
CT scan, pulmonary nodules;

Secondary

MeasureTime frame
Serum immunology;Tumor marker;

Countries

CHINA

Contacts

Public ContactWei Youzhen

Jinan People's Hospital (Affiliated People's Hospital, Shandong First Medical University)

wei-youzhen@163.com+86 133 1199 6836

Outcome results

None listed

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