None listed
Conditions
Interventions
Intervention1: 8.4% Sodium Bicarbonate Oral Spray: ORAL SPRAY (Test A)
Sr. No. Material Name Label Claim Suggested Limit
01 Sodium Bicarbonate 8.4% 4.2 â?? 8.4
02 Glycerine 8.0% 4.0 â?? 12.0
03 Pro
Sponsors
Myself Health Check Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be included in the study: 1) Age: Adult 18 years inclusive and above at the time of consent. 2) Sex: Adult, healthy males and non-pregnant/non-lactating females. 3) Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects including absence of symptom or signs of Covid-19 infection or any other ILI. 4) Subjects must be able to understand and provide written informed consent to participate in the study. 5) Subjects with no relevant findings in medical history or on physical examination which would suggest to the P.I. that the subject is unsuitable for inclusion in the study. 6) Subjects who are willing to allow the Investigator to register volunteer details with a confidential database (The - Over-Volunteering Protection Service) to prevent concurrent entry into clinical studies/trials. 7) Subjects who are able and willing to comply with all the trial requirements.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1) Subjects who have a clinically significant active Oral Cavity disease. 2) Subjects who have a history of recent Oral ongoing treatment. 3) Subjects who have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk. 4) Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months. 5) Subjects who are currently participating in any another study related to Oral applications. 6) Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study or have participated in a clinical study in the recent past up to three months. 7) Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated. 8) Subjects who are Pregnant, lactating or have the intention to become pregnant during trial period as determined by questioning the subject. 9) Subjects with any pharyngeal, or laryngeal finding which precludes bronchoscopy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects not getting ILI symptoms at the end of the study using the Flu-Pro Plus Patient Reported Outcome Measure (PROM).Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety and tolerability of an aerosol having as its active ingredient 8.4 % sodium bicarbonate and xylitol 5% when administered to the nasopharynx and oropharynx.Timepoint: 2 months | — |
Countries
India
Contacts
Public ContactKshitij Mody
Welcare Hospital
Outcome results
None listed