Clinical study to check the effectiveness and safety of AphtoFix® Mouth Ulcer Cream in subjects suffering from mouth ulcer.
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2014/08/004918
- Lead Sponsor
- Bonyf AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female subjects with 18 â?? 65 years of age (both
inclusive).
2. Subjects having mouth ulcer size >2 mm in locations for easily
accessible for evaluation and treatment.
3. Subject with time of onset of mouth ulceration within 48 hours.
4. Subject who agreed, not to use any other medication to treat
mouth ulcer during study period.
5. Subject willingness to comply with the study schedule and
procedures.
6. Subject / legally acceptable representative (LAR) of subject
willing to sign and date written informed consent to participate
in the study. However, if the subject/LAR of subject is illiterate,
the impartial witness would sign the ICF.
1. Subjects with a history of allergy for content present in
AphtoFix®
2. Subjects with any invasive dental procedures within 2 weeks
prior to screening visit.
3. History of uncontrolled chronic disease (e.g. chronic liver
disease, chronic renal disease)
4. Use of any other medication to treat mouth ulcer in current
episode.
5. Participation in any other clinical study during last 30 days.
6. Subject with any condition which in the opinion of the
investigator makes the subject unsuitable for inclusion.
7. Subject is a female who is pregnant or willing to get pregnant,
not ready to use contraceptive measures during the trial period,
or is breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Ulcer size reduction. <br/ ><br>- Reduction in number of ulcers. <br/ ><br>- Pain reduction by assessing pain intensity.Timepoint: 14 days
- Secondary Outcome Measures
Name Time Method - Duration of ulcer (Days need for complete healing). <br/ ><br>- Number and frequency of application. <br/ ><br>- Quality of life evaluation using mouth ulcer QOL <br/ ><br>Questionnaire.Timepoint: 14 Days