A Clinical Study To Evaluate The Taste And Sensation Effects of two formulations of Nimorazole in Clinically Healthy Adults.
- Registration Number
- CTRI/2014/01/004328
- Lead Sponsor
- DeVats India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1.Clinically healthy adults between the ages of 18 and 50 (both sexes)
2.Subject who understand and willing to sign informed consent document before start of any study specific assessment.
3.Subject has not participated in a similar investigation in the past four weeks.
1.Subject who have known history of misplaced taste perceptions
2.Subjects who are smokers or have quit smoking within the last 6 months.
3.Subjects who are currently having or recently has upper respiratory or middle ear infections
4.Subjects who have recently undergone chemotherapy/ radiation treatment for head and neck cancers.
5.Subjects with recent surgeries to the ear, nose, throat including wisdom tooth extraction in the past 4 weeks.
6.Subjects with Olfactory disorders such as anosmia, partial anosmia, hyposmia, hyperosmia, dysosmia, phantosmia, olfactory agnosia.
7.Subjects with poor oral hygiene, mouth ulcers or other dental problems such as gingival or periodontal infections.
8.Subjects with history of thyroid imbalances.
9.Subjects who are on treatment with DMARD, anti inflammatory drugs, immunosuppresents for the past 6 months before inclusion into the trial.
10.Subjects who are planning a pregnancy, reported pregnant or lactating.
11.Subjects, who in the opinion of the Investigator are not eligible for enrollment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Score of 7 in the Gustatory Taste Test Questionnaire. <br/ ><br>2.Score of 18 in the Gustatory Taste test Questionnaire â?? Rating. <br/ ><br>Timepoint: 1. Screening <br/ ><br>2. Period 1 <br/ ><br>3. Period 2 - (After washout period of 2 hours) 0 end of study
- Secondary Outcome Measures
Name Time Method 1.Score of 3 â?? 6 in the Gustatory Taste Test Questionnaire. <br/ ><br>2.Score of 11 â?? 17 in the Gustatory Taste Test Questionnaire â?? Rating. <br/ ><br>Timepoint: 1. Screening <br/ ><br>2. Period 1 <br/ ><br>3. Period 2 - (After washout period of 2 hours) 0 end of study