A Phase-3 multi centre, randomized, parallel, double blind, placebo control, clinical study to determine the efficacy and safety of Betadine Nasal spray Povidone Iodine IP 0.5% w/v for the treatment of Rhinitis in patients suffering from Rhinitis associated with Upper respiratory tract infection along with standard care of therapy. - NI

G.S. Pharmbutor Private Limited0 个研究点目标入组 192 人开始时间: 待定最近更新: 2024年4月1日

研究概览

暂无简介。

•Any subject who meets all of the following inclusion criteria will be eligible for the trial.
•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 associated with Upper Respiratory tract infection (such as laryngitis,
•pharyngitis, tonsilitis and sinusitis).
•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)

•Any subject who meets at least one of the following exclusion criteria will not be eligible for the trial.
•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, but not restricted to medicated rhinitis,
•vasomotor and atrophic;
•6. Participant’s 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

G.S. Pharmbutor Private Limited