To assess the Skin sensitivity of Amrutanjan pain balm
Phase 4
Completed
- Registration Number
- CTRI/2023/03/051035
- Lead Sponsor
- Amrutanjan Health Care Limited, Tamil Nadu, India.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1.Patients of either sex aged above 18 years.
2.Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
Exclusion Criteria
1.Past history of allergy, asthma and atopy.
2.Known allergy to compounds of investigational product.
3.Participation in an investigational drug trial in the 30 days prior to the screening visit.
4.Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
5.Subjects with known history of Sinusitis, Migraine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following parameters will be assessed for each subject; <br/ ><br>1. Erythema/dryness/wrinkles <br/ ><br>2. Oedema <br/ ><br>3. Mean Irritation Index <br/ ><br> <br/ ><br>Clinical score for Erythema/ Dryness/Wrinkles/oedema : scale 0-4 <br/ ><br>Scale: Reaction <br/ ><br>0- No reaction <br/ ><br>1- Very slight erythema/dryness withshiny appearance/very slight oedema <br/ ><br>2 - Slight erythema/dryness/wrinkles/slight oedema <br/ ><br>3 - Moderate erythema/dryness/wrinkles/moderate oedema <br/ ><br>4 - Severe erythema/wrinkles/scales/severe oedema <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
- Secondary Outcome Measures
Name Time Method Time to onset of skin irritation/burning sensation Time frame: 0-8 hrs post dose <br/ ><br> <br/ ><br>Time taken for complete relief of skin irritation/burning sensation. <br/ ><br>User perception will be assessed with a 5- point Likert Satisfaction scale on the following points: <br/ ><br>1. Ease of application, <br/ ><br>2. Stickiness 3. Greasiness and 4. Ease of spreading. <br/ ><br>To monitor for any adverse events during the study period. <br/ ><br>Timepoint: Time frame: 0-8 hrs post dose <br/ ><br>