Clinical trial of â??AHPL/AYTOP/2014Aâ?? Gel in mouth ulcer

Phase 3

Completed

Conditions: Health Condition 1: null- Aphthous Ulcer

Registration Number: CTRI/2017/04/008386

Lead Sponsor: Ari Healthcare Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients clinically diagnosed as aphthous ulcers

2.Minor Mouth ulcers that have appeared less than a week prior to the enrollment

3.Ulcers at accessible locations (labial, buccal mucosa, tongue preferably)

4.Who can make all necessary visits and comply with the study procedures

5.Subject willing to participate in clinical trial and who have read, understood and signed informed consent form

Exclusion Criteria

1.Subjects Suffering from any other oral or dental disease or active skin disease.

2.Patient under treatment of ulcers with systemic steroids, vitamins, antibiotics, antihistamines, oral Retinoids or immunomodulatory agents within three months before study entry.

3.Patients having any major systemic diseases including genetic, endocrinal diseases, cancer, HIV, AIDS

4.Known cases of hematological disorders, ulcerative colitis or Crohns disease.

5.Patient who had a history of probable sensitivity to any mouthwash or toothpaste

6.Patients having Anemia or known iron, folic acid, Vit. B12 deficiency

7.Patient having addiction of alcohol or smoking or tobacco chewing

8.Pregnant or lactating women

9.Patients having known hypersensitivity to ingredients used in the study drugs

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in pain as perceived by patient using VASTimepoint: Day 0, Day 3, Day 7, Day 10, Day 14

Secondary Outcome Measures

Name	Time	Method
1.Changes in burning sensation <br/ ><br>2.Number of completely healed ulcers. <br/ ><br>3.Number of days required to heal the ulcers <br/ ><br>4.Percentage of healing of Index ulcer <br/ ><br>5.Changes in ease of consumption of solid and liquid food. <br/ ><br>6.Onset of action and duration of action <br/ ><br>7.Overall improvement of treatment by patient and physician. <br/ ><br>8.Consistency, Taste, Local tolerability, Ease of application of test drugs <br/ ><br>9.Adverse events and Tolerability of trial drugsTimepoint: Day 0, Day 3, Day 7, Day 10, Day 14