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Clinical trial to evaluate efficacy and safety of PVPI-0.45% w/v throat spray administered along with standard care of therapy in patients suffering from tonsilitis and pharyngitis (infections)

An investigator initiated, Single center, double blind, placebo control, randomized, pilot clinical study to evaluate Efficacy and Safety of PVPI-0.45% w/v throat spray administered along with standard care of therapy in patients suffering from tonsilitis and pharyngitis (infections).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044866
Enrollment
10
Registered
2022-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J029- Acute pharyngitis, unspecified Health Condition 2: J039- Acute tonsillitis, unspecified

Interventions

Intervention1: PVPI-0.45% w/v: Product to be administered 2-3 sprays, 3 times daily Duration - 5 days Route of Administration -Inhaler Control Intervention1: Placebo Spray: comparator product to be a

Sponsors

Dr Harsh Mittal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male/Female patients aged between 18-65 years 2.Clinical diagnosis of acute tonsillitis/pharyngitis 3.Willingness to comply with the study schedule and procedures. 4.Subjects willing to give written informed consent prior to screening.

Exclusion criteria

Exclusion criteria: 1.Subjects not willing to give written informed consent 2.Subjects who is willing to adhere to hot water saline gargle. 3.Known cases of Thyroid dysfunction. 4.Patients undergone thyroidectomy. 5.Immunocompromised patients. 6.Known hypersensitivity to any ingredient of the study drug. 7.Severe sepsis 8.Advanced Tonsilo-Pharyngeal disease/ infection. 9.Pregnancy and Lactation. 10.Subject with any condition which in opinion of the investigator makes him/her unsuitable for exclusion.

Design outcomes

Primary

MeasureTime frame
ââ?¬Â¢ To evaluate the efficacy of PVP-I Throat spray 0.45% w/v in patients as changes in reduction of symptoms (sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat) on a 5-point Likert scale. o0- Absence of symptoms o1-Mild symptoms o2-Moderate symptoms o3-Severe symptoms o4-Very severe To analyze change in bacterial and viral load in the throat done by oropharyngeal swab collection Timepoint: Baseline 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

MeasureTime frame
ââ?¬Â¢To assess change in response rate and level of remission from baseline to day 5 [time taken in 50% reduction in the main complaints (sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat, Overall time taken for remission ââ?¬Â¢Quality of Life as judged by the patients by STQoL (Sore Throat Quality of Life Questionnaire) ââ?¬Â¢Number of Participants Experiencing Adverse Events throughout the study period Timepoint: Baseline 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

harshmittal86@gmail.com9560506410

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026