Health Condition 1: K120- Recurrent oral aphthae
Conditions
Interventions
Intervention1: LIQUID APPLICATOR: The product is an Applicator with 2 ampules inside each with a liquid form of active ingredients (after breaking the 1 ampules and mixing the 2 liquids) Trichloro ace
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 � Patients with only one Aphthous wound. � Only Ulcers that are present in the following anatomical spots will enrolledin the study: superior and inferior inner lip, inner cheek (buccal) and hard palate (the place of the aphthous will be stated in the Case Report Form). � Patients with start of mouth ulceration within 48 hours � Patients who agree not to use any other medication 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. Females likely to become pregnant during conducting of the study 8. Pregnant and Lactating females. 9. 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 10. Consumption of vaping products 11. Any major illness in the last 03 months or any significant ongoing chronic medical illness. 12. Evidence of allergy or known hypersensitivity to Liquid Applicator and its components. 13. 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. 14. Use of any other medications for aphthous ulcer within 01 week prior to screening 15. Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion 16. Patients with Malignancy or a history of malignancy 17. Patients with Positive results for HIV or Hepatitis B or C 18. Immunocompromised patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the intensity of pain during 10 seconds administration on dosing day (Day 01) 2. Mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, 07 and Day 10 which is measured by scale or Vernier caliper whichever is applicable. 3. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 03, 07 and day 10.Timepoint: 1. To determine the intensity of pain during 10 seconds administration on dosing day (Day 01) 2. Mean of aphthous ulcer size reduction (Days required to heal the ulcer) on Day 03, 07 and Day 10 which is measured by scale or Vernier caliper whichever is applicable. 3. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 03, 07 and day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/APTimepoint: N/AP | — |
Countries
India
Contacts
Public ContactDrSuman G
RAJALAKSHMI HOSPITAL
Outcome results
None listed