Health Condition 1: J308- Other allergic rhinitis
Conditions
Interventions
Intervention1: Betadine Nasal spray Povidone Iodine IP 0.5% w/v: Both test and comparator product to be administered 2-3 sprays in each nostril, 3 times daily.
Control Intervention1: Placebo Spray: Co
Sponsors
Dr Harsh Mittal
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ability to confirm voluntary participation and sign the informed consent form 2.Participants of both sexes, aged between 18-65 years. 3.Clinical diagnosis of acute rhinitis 4.Total nasal symptom scores greater than or equal to 6 points, with congestion and one or more of the other symptoms present (itching, runny nose, and sneezing)
Exclusion criteria
Exclusion criteria: 1.History of alcohol abuse or illicit drug use; 2.Participation in a clinical trial in the year before this study; 3.Pregnancy or risk of pregnancy and lactating patients; 4.Known hypersensitivity to the formula components used during the clinical trial; 5.Participants who present other clinical forms of rhinitis, such as, but not restricted to medicated rhinitis, vasomotor and atrophic; 6.Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy; 7.Participants with suggestive signs of upper airways bacterial infection; 8.Participants with grade II or III septum deviation and/or presence of nasal polyps or other conditions that lead to nasal obstruction; 9.Concomitant chronic or intermittent use of decongestants, antihistamines, or corticosteroids by inhalation, oral, intramuscular, or intravenous; 10.Concomitant use of potent topical corticosteroids. 11.Sinus surgery within 30 days of beginning the study. 12.Intubated at the time of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Total Nasal Symptom score (TNSS) Annexure-I Total Nasal symptom score a composite of 3 symptoms (Sneezing, Nasal Congestion and Rhinorrhea) ââ?¬Â¢ To Aanalyse change in Bacterial and Viral load in nasal cavity. Nasopharyngeal swabs to be obtained and testing to be performed to determine the viral load and Bacterial load in the nasopharynxTimepoint: Visit ââ?¬â?? V-1 (Day1), V-2(Day 3 at same time (Ã?±1 Hour) of visit 1) & End of Study Visit- V3(Day 5 at same time (Ã?±1 Hour) of visit 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Quality of Life as judged by the patients using GHQ-12 questionnaire(Annexure-II) ââ?¬Â¢ Number of patients with no nasal congestion, ease in breathing as a measure of Tolerability ââ?¬Â¢ Number of Participants Experiencing Adverse Events throughout the study period. AE assessment to include but not limited to following parameters: Nasal burning/pain Headaches Ear Pain sneezing Nose bleedsTimepoint: Visit ââ?¬â?? V-1 (Day1), V-2(Day 3 at same time (Ã?±1 Hour) of visit 1) & End of Study Visit- V3(Day 5 at same time (Ã?±1 Hour) of visit 1) | — |
Countries
India
Contacts
Public ContactDr Harsh Mittal
Panchsheel Hospital Private Limited
Outcome results
None listed