Health Condition 1: null- Sore throat due to Acute Pharyngitis
Conditions
Interventions
Intervention1: LPOTC002-11: 3-4 aspirations every 3 hours up to 4 times daily for 3(+2)days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Laila Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female and male subjects between the age of 18 and 65 years. 2.Sore throat due to acute pharyngitis (not more than 72 hours) 3.The throat pain intensity is rated at least moderate on the verbal rating scale 4.Willingness to remain at the study centre for two hours following the first dose of study medication and return three to five days later. 5.Willing to take nothing by mouth except study medication for two hours following the first application of study product. Subjects must also not smoke during this time period. 6.Females of childbearing potential must agree to use a medically approved form of birth control and have a negative urine pregnancy test result throughout the study. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy 7.The subject has provided written informed consent prior to any study-related procedures.
Exclusion criteria
Exclusion criteria: 1.Female subjects who are pregnant or lactating 2.First indication of symptoms of acute pharyngitis (e.g. sore throat) occurred more than 3 days ago. 3.Subjects who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 4.Subject who have taken antibiotics, analgesics, anti-inflammatory agents, steroids for oral, inhaling or topical application expectorants or antitussives in the past week or will require these treatments during the study. No physical therapy (e.g. throat compress, throat rinsing) may be applied during the trial. 5.Subjects with mouth breathing as a result of nasal congestion. 6.Known hypersensitivity to curcuminoids, olive leaf extracts or any excipients contained in the throat spray. 7.Cough that causes throat discomfort 8.Active pulmonary disease such as bronchopneumonia 9.Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours 10.Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours 11.Use of an antibiotic for an acute illness within last 24 hours 12.Use of inhaled steroids or beta-agonists on a continuous basis during the last week 13.Existing tumour condition currently under treatment. 14.Alcohol, and/or drug abuse. 15.Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication. 16.Any investigational therapy within 30 days prior to the enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the pain intensity from baseline to end of the study recorded on verbal rating scale from 0-2 hours every day. The subject rates his/her pain intensity on a six-point verbal rating scale before using the IP (0 hour) and after the first spray application (02 hours).Timepoint: Day 1 (Baseline) and Day 3(+2)End of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Assessment of the efficacy of throat spray at the end of each treatment day by the subject on a 4-point verbal rating scale. â?¢Final global assessment of efficacy by the subject and investigatorTimepoint: Day 3(+2)End of the trial | — |
Countries
India
Contacts
Public ContactMr Sanjib Kumar Panda
Laila Pharmaceuticals Pvt. Ltd
Outcome results
None listed