Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
None listed
Sponsors
Inzpera Healthsciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Parents or legal guardians willing to sign written informed consent form for the child and child willing to sign assent form for participation 2. Children and parents / guardians who agree to comply with study requirement and schedule Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat; 3. Should be more than 7 years of age and less than or equal to 12 years of age at the time of inclusion into the study; 4. Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study; 5. Tonsillopharyngitis Severity Score (TSS) � 5 (TSS consist of sore throat, dysphagia, secretions and erythema). Baseline modified Centor score � 2 (total score) 6. Subjects with throat symptoms and fever on patient reported outcome measures: sore throat pain rated more than or equal to 66 mm on the Sore Throat Pain Intensity Scale (STPIS) and fever more than 98.60 F
Exclusion criteria
Exclusion criteria: 1. Use of analgesics within 2. Use of antibiotics within 3. Use systemic or inhaled corticosteroids within ââ?°Â¤1 months prior to the study start and planned therapy of them during the study (besides skin means). 4. Subjects presenting with bronchitis, severe pharyngitis, severe tonsillitis 5. Highly infected and inflamed tonsillitis pediatric patients. 6. Subjects with any other chronic illness such as asthma, heart blocks, any congenital anomaly 7. Subjects having sensitivity reaction to components of CurkeyïÆ?¢ or antibiotics suggested in the reference group. 8. Subjects will be ineligible if they displayed confounding features of URTI: mouth breathing which causes throat drying, coughing which causes throat discomfort, or any disease that could compromise respiratory function. 9. Subjects will be also ineligible if they had a history of allergic reaction or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs, or any gastrointestinal, hepatic, or renal dysfunction. 10. Subjects will be excluded if they had to use any throat lozenge, throat spray, cough drop, or menthol-containing product within one hour prior to study screening, used any ââ?¬Ë?cold medicationââ?¬• or immediate release analgesic within the previous four hours, used any sustained-release analgesic within the previous 12 hours, taken an antibiotic for an acute disease within 24 hours, or any quinolone antibiotic or inhaled therapy in the previous week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoint(s) Efficacy will be evaluated based on the following parameters comparing intra-patients for Group A and the two treatment arms from baseline to end of treatment for Group B 1. Proportion of subjects with reduction of Tonsillopharyngitis Severity Score [TSS 50%] 2. Global assessment of efficacy 3. Visual analog [VAS] scale 4. Modified Centor Scale[MCS] 5. Tonsillo-Pharyngitis Assessment [TPA] scale ââ?¬Æ? Timepoint: Base line, 3rd day, 7th day | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the Safety of CurkeyÃ?® when administered with standard treatment in acute, viral, uncomplicated upper respiratory tract infection in children of 7-12 years of age Timepoint: 1st day, 3rd day, 5th day | — |
Countries
India
Contacts
Public ContactDr Sumitra Venkatesh
Bai Jerbai Wadia Hospital for childrens
Outcome results
None listed