Health Condition 1: J39- Other diseases of upper respiratory tract
Conditions
Interventions
Intervention1: MUCOADHESIVE TABLET: The product is a Muco-adhesive tablet with active Ingredient Sodium Hyaluronate 0.5% manufactured by Tree of Life Pharma Ltd. Dose : 120 mg Duration of Therapy : 3
Sponsors
Rajalakshmi Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients with acute sore throat above 18 years 2. >4 points on a visual analog scale (VAS). 3. >75 mm on Sore Throat Pain Intensity Scale (STPIS). 4. Patients should have sore throat within 4 days 5. Willing to comply with all requirements of this study protocol as well as instructed by the study personnel. 6. Patients who agree not to use any other medication for the sore throat during the study period. 7. No clinically significant abnormal finding on Medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems).
Exclusion criteria
Exclusion criteria: 1. Patient had been sore throat for more than 4 days 2. Evidence of mouth breathing or severe coughing, existence of other distracting pain. 3. Patients were also excluded if they had used any sore throat medication containing a local anaesthetic within the previous 4 hours. 4. Analgesic, antipyretic, or cold medication (such as decongestant, antihistamine, antitussiveor throat lozenge/spray) within the previous 8 hours. 5. A longer acting or slow-release analgesicduring the previous 24 hours (for examplepiroxicam, naproxen). 6. Any medicated confectionary, throat pastille, spray, or any product with demulcent properties (such as boiled sweets) in the previous 2 hours or antibiotics inthe previous 14 days. 7. The patient with Oral lesion suspected to be malignant 8. If the patient has undergone any experimental oral intervention within the last 24 hours. 9. History of alcohol addiction or abuse. 10. Patient who had participated in any other study within the 90 days of study 11. Patient who are not willing to enter the dosing details in their diary. 12. Females likely to become pregnant during conducting of the study 13. Pregnant and Lactating females. 14. Consumption of tobacco containing products Tobacco and tobacco products (like Khutkha, Pan/ Pan Masala, Beedi, Cigarettes) for at least 24.00 hours prior to screening and throughout the entire study 15. Consumption of vaping products 16. Any major illness in the last 03 months or any significant ongoing chronic medical illness. 17. Evidence of allergy or known hypersensitivity to Muco-Adhesive tablets, Strpesils and its components. 18. History of dehydration from diarrhea, vomiting or any other reason within a period of 48.00 hours prior to study check-in of each visit. 19. Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion 20. Patients with Malignancy or a history of malignancy 21. Patients with Positive results for HIV or Hepatitis B or C 22. Immunocompromised patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 01 before the treatment and on Day 03 and Day 08.Timepoint: 1. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 01 before the treatment and on Day 03 and Day 08. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/APTimepoint: N/AP | — |
Countries
India
Contacts
Public ContactDrSuman G
Rajalakshmi Hospital
Outcome results
None listed