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A pilot study assessing the safety and tolerability of cold plasma therapy in healthy volunteers

A pilot study assessing the safety and tolerability of cold plasma therapy in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100053
Enrollment
Unknown
Registered
2025-04-02
Start date
2024-11-27
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None

Interventions

Intervention group:First, 3 healthy people were selected, and the self-developed cold plasma therapy system was used to treat the right forearm for 30s, once a day, for 7 consecutive days, and the ind
Increment or decrement by 1 step at a time, and the experiment in the later gear can only be continued after the intervention of the predetermined parameters of the current gear has been completed and

Sponsors

General Hospital of Eastern Theater Command, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers, both male and female; 2. Age: 18 years old or above; 3. Weight: within the range of 19 to 26 (inclusive of 19 and 26) as calculated by body mass index = weight (kg)/height^2 (m^2); 4. Good physical health (no significant clinical symptoms, no abnormal laboratory findings of clinical significance); 5. Participants volunteered to take part in the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have skin symptoms such as dandruff, itching, crusting, erythema, and pimples. 2. Have clinically significant laboratory abnormalities or other clinically significant exclusionary diseases (including but not limited to renal, hepatic, gastrointestinal, cardiovascular, and neurological diseases); Virological indicators such as anti-HIV antibody IgG, hepatitis C virus antibody, hepatitis B virus surface antigen, and Treponema pallidum specific antibody were positive. 3. Have a definite history of central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, blood system, metabolic and musculoskeletal system; 4. Those who do not meet the health standards of the subjects in the physical examination: awake heart rate =140mmHg, diastolic blood pressure = 90mmHg, or forehead temperature>37.3°C; 5. Allergies: such as allergies to two or more drugs and food; Those who have a history of allergies to ultraviolet rays, radiation, etc.; 6. Those with a history of smoking (more than 5 bottles/day or using a considerable amount of nicotine products), alcohol abuse (drinking more than 14 units of alcohol per week: 1 alcohol unit is equal to 10mL or 8g of pure alcohol, 25 mL of 40% liquor, 330 mL of 5% beer, and 175mL of 12% red wine are about 1.0, 1.5, and 2.0 alcohol units, respectively), drug abuse, and drug abuse; 7. Those who have a family plan during the trial or within 3 months after the end of the trial (including male subjects); 8. Those who have a history of blood donation within 2 months before the test; 9. Those who have taken various medications (including Chinese herbal medicines) in the past 2 weeks; 10. Smoking or using any food or drink containing alcohol, xanthine or grapefruit (including chocolate, tea, coffee or cola drinks, etc.) within 48 hours before the intervention; 11. Those who have participated in clinical trials of other drugs or devices within 3 months before the intervention; 12. Patients with difficulty in venous blood collection; 13. The patient does not cooperate with the treatment.

Design outcomes

Primary

MeasureTime frame
Erythra;Allergies;Paronychia;Stomatitis;Diarrhea;Nausea and fatigue;

Secondary

MeasureTime frame
Localized skin lesions;Local itching;Liver and kidney function;

Countries

China

Contacts

Public ContactWeiqin Li

General Hospital of Eastern Theater Command, PLA

liweiqindr@nju.edu.cn+86 139 5183 9654

Outcome results

None listed

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