None listed
Conditions
Interventions
Intervention1: A solution containing 8.4% Sodium Bicarbonate & 5% Xylitol along with other excipients: NASAL SPRAY -
Sodium Bicarbonate 8.4 %
Glycerine 8.0%
Propylene glycol 5.0%
Xylitol 5.0%
Benzalk
Sponsors
Myself Health Check Ltd
Dr Bharat Mody
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: For adult 18 years and above at the time of consent. 2) Sex: For adult, Healthy male and Non-pregnant/non-lactating females, 3) Females of childbearing potential and menarche children both must have a negative urine pregnancy test performed on screening visit. 4) Use effective contraception (see below) for the duration of the trial period (females only) 5) Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects, including absence of any symptoms/signs of covid-19 infection or any other ILI. 6) Subjects must be able to understand and provide written informed consent to participate in the study. 7) Chest radiograph normal 8) No relevant findings in medical history or on physical examination 9) Able and willing to comply with all the trial requirements
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating female subjects should be excluded as these conditions impact the condition of the skin. 2) Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse. 3) Subjects who have a clinically significant active Oral Cavity and Nasal disease. 4) Subjects who have a history of recent Oral or Nasal Surgery or ongoing treatment. 5) 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. 6) Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months. 7) Subjects who have history of an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.). 8) Subjects who are currently taking any immunosuppressant medication. 9) Subjects who have history of insulin-dependent diabetes. 10) Subjects who have history of asthma or any other chronic respiratory condition requiring daily therapy. 11) Subjects who are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis. 12) Subjects who are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start. 13) Subjects who are currently participating in any another study related to Oral and Nasal applications. 14) Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study. 15) Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated. 16) Pregnancy, lactation or intention to become pregnant during trial period Any respiratory disease, including asthma 17) Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy 18) Past treatment for TB disease 19) Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the preventive strength of the aerosol containing as its active ingredient 8.4 % sodium bicarbonate when administered to the nasopharynx and oropharynx against the development of Influenza Like Illness (ILI) including Covid-19 infection in the general as well as high risk population as assessed by 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: 6 months | — |
Countries
India
Contacts
Public ContactDr Vidhi Hingu
Welcare Hospital
Outcome results
None listed