Health Condition 1: K120- Recurrent oral aphthae
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: � Adult,non smoking, human above 18 years � Willing to comply with all requirements of this study protocol as well as instructed by the study personnel. � Mouth ulcer size >2 mm but � Only Ulcers that are present in the following anatomical spots will enroll in the study:superior and inferior inner lip, inner cheek (buccal), hard palate.(the place of the aphthous will be stated in the case report form. � Patients with only one Aphthous wound � Patients with start of mouth ulceration within 48 hours � Patients who agree not to use any othermedication for the ulcer during the study period. � 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. Patients with multiple aphthous in the mouth during the visit 2. The patient with Oral lesion suspected to be malignant 3. The patient with any Ulcerative oral lesion other than Aphthous stomatitis. 4. If the patient has undergone any experimental oral intervention within the last 24 hours. 5. History of alcohol addiction or abuse. 6. Patient who had participated in any other study within the 90 days of study 7. Patient who are not willing to enter the dosing details in their diary. 8. Females likely to become pregnant during conducting of the study 9. Pregnant and Lactating females. 10. 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 11. Consumption of vaping products 12. Any major illness in the last 03 months or any significant ongoing chronic medical illness. 13. Evidence of allergy or known hypersensitivity to Muco-Adhesive tablets and its components. 14. 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. 15. Use of any other medications for aphthous ulcer within 01 week prior to screening 16. Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion 17. Patients with Malignancy or a history of malignancy 18. Patients with Positive results for HIV or Hepatitis B or C 19. Immunocompromised patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, Day 07 andDay 10. 2. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 1 before the treatment and after the first tablet, Day 03 or Day 07 or day 10Timepoint: 1. To determine the mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, Day 07 andDay 10. 2. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 1 before the treatment and after the first tablet, Day 03 or Day 07 or day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| N/APTimepoint: N/AP | — |
Countries
India
Contacts
Public ContactDrSuman G
RAJALAKSHMI HOSPITAL
Outcome results
None listed