Health Condition 1: J039- Acute tonsillitis, unspecified
Conditions
Interventions
Intervention1: Betadine PVPI-0.45 percentage weight per volume Throat Spray
: Dose-0.45 percentage weight per volume Throat Spray
Frequency- One or two spray, 3-4 times a day
Duration- 5 days
Control
Sponsors
GS Pharmbutor Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the changes in Tonsillopharyngitis sign and symptoms – [Time frame: Baseline to EOT(Day6)] Efficacy will be analyzed with the help of a 5-point Likert scale on the following sign and symptoms i.e., Sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat. 5-point Likert scale includes 0-Absence of symptoms 1-Mild symptoms 2-Moderate symptoms 3-Severe symptoms 4-Very severeTimepoint: upto day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the average time taken to reduce or remission of the main Tonsillopharyngitis sign and symptoms of 5 days treatment regimen. Time taken in 50 percentage reduction in the main complaints i.e., sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat [Time frame: Baseline to EOT (Day 6)] 2.No statistically significant difference in Thyroid Function Test (TFT) after 5 days of completion of therapy. TFT to be done on day 01 and 06 in the treated population compared to placebo. 3.Quality of life will be evaluated based on STQoL (Sore Throat Quality of Life) questionnaire. 4.Adverse events (AEs) monitoring during the study period. 5.Oropharyngeal soft tissue irritation or tolerability of IP assessment 6.Physical examination & vital signs.Timepoint: upto Day 6 | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
Kothalkar Clinic
Outcome results
None listed