An investigator initiated, Single center, double blind, placebo control, randomized, pilot clinical study to evaluate Efficacy and Safety of Betadine Nasal spray Povidone Iodine IP 0.5% w/v for decontamination and decolonization of Nasal mucosa in patients suffering from Rhinitis.

Dr Harsh Mittal0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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)

•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

发起方

Dr Harsh Mittal