A Phase-III multi centre, randomized, parallel, double blind, placebo control, clinical study to determine the efficacy and safety of Betadine PVPI-0.45 % weight per volume throat spray, applied along with standard of care therapy in patients suffering from Tonsillitis and Pharyngitis (throat infections). - NI

GS 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29日

研究概览

暂无简介。

•1.Males and females aged 18 -65 years older at the time of screening.
•2.Presence of at least two sign and symptoms at the time of screening e.g., sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat.
•3.Participants who will be able to provide written informed consent prior to the performance of any study specific procedures.
•4.Female participants of child-bearing potential with negative urine pregnancy test at the time of screening.
•5.Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule

•1.Known cases of Thyroid dysfunction as per medical history taken by Investigator at the time of screening.
•2.Patients undergone or planning to go for thyroidectomy.
•3.If the patient has goiter, thyroid nodules, or other thyroid diseases.
•4.Known hypersensitivity to any ingredient of the study drug.
•5.Severe sepsis
•6.Advanced Tonsilo Pharyngeal disease or infection
•7.Pregnant and Lactating women
•8.Subjects who take any medication likely to interfere with the study.
•9.Subjects who are unwilling or unable to give written inform consent.
•10.Patients involved in clinical trials and taken Investigational drugs within 30 days of enrolment.

发起方

GS Pharmbutor Private Limited