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Clinical trail of seawater nasal spray device

Efficacy and safety of physiological seawater nasal spray device as add-on therapy in patients with acute upper respiratory infection: a multi-centre, randomized, prospective, and blank-controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031171
Enrollment
Unknown
Registered
2020-03-23
Start date
2018-05-04
Completion date
Unknown
Last updated
2020-03-30

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

Conditions

acute upper respiratory infection

Interventions

seawater group:both basis treatment and nasal irrigation with seawater
control group:basis treatment only

Sponsors

Jiangxi Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. volunteers aged 18 to 65 years, with a duration of symptoms no longer than 72 hours; 2. The acute URI was defined by the presence of at least two of the following 10 symptoms: sneezing, running nose, nasal congestion, headache, myalgia, throat discomfort, sore throat, dysphonia, cough and fever. Symptoms of nasal congestion and running nose should be showed; 3. Patients agreed to participate in the test and sign the informed consent; 4. Well compliance and willing to cooperate to complete the whole clinical trials.

Exclusion criteria

Exclusion criteria: Volunteers were excluded from the study if they met any of the following criteria: 1. pregnancy or breastfeeding; known hypersensitivity to seawater; 2. use of alcohol or illicit drugs; 3. with other?respiratory diseases combined (such as herpangina,suppurative tonsillitis, bronchitis, chronic rhinitis, etc); 4. any current acute disease or uncontrolled exacerbation of chronic disease; 5. serious systemic diseases;need for antiviral therapy to treat influenza A or B infection; 6. need for antibacterial therapy to treat acute respiratory infection; 7. use of medication to treat conditions acquired before inclusion; 8. and participation in another clinical trial less than 3 month before;and patients likely to have poor compliance or that were unlikely to complete the trial, as determined by the investigators.

Design outcomes

Primary

MeasureTime frame
effective rate of nasal congestion;effective rate of running nose;

Secondary

MeasureTime frame
symptom score of nasal congestion;symptom score of running nose;symptom score of sleep quality;symptom score of appetite;symptom score of cough;symptom score of fatigue;

Countries

China

Contacts

Public ContactJiang Min

Jiangxi Provincial People's Hospital

jmjxnc@163.com+86 13037200789

Outcome results

None listed

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