To assess the Skin sensitivity of Amrutanjan pain balm

Phase 4

Completed

Brief Summary: The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 12 healthy adult subjects will be divided into 2 arms with 6 in each. Six Subjects will be topically applying the pain balm of product A and six subjects will be topically applying Product B over forehead region and they will be in house for a period of 8 hours and monitored at 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs for clinical scores of erythema/dryness/wrinkles/oedema. Then a wash out period of 5 days is given. Patients with any erythema/ oedema will not be included for the Subsequent study procedure. Then, the subjects will be crossed over and the same procedures will be repeated. The following parameters will be assessed for each subject; Erythema/dryness/wrinkles Oedema Mean Irritation Index

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
The following parameters will be assessed for each subject;	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
3. Mean Irritation Index	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
Scale: Reaction	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
1. Erythema/dryness/wrinkles	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
2. Oedema	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
1- Very slight erythema/dryness withshiny appearance/very slight oedema	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
2 - Slight erythema/dryness/wrinkles/slight oedema	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
Clinical score for Erythema/ Dryness/Wrinkles/oedema : scale 0-4	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
0- No reaction	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
3 - Moderate erythema/dryness/wrinkles/moderate oedema	Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
4 - Severe erythema/wrinkles/scales/severe oedema	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	Time taken for complete relief of skin irritation/burning sensation.

Locations (1): Thirumalai Medical Centre, Puducherry
🇮🇳
Pondicherry, PONDICHERRY, India
Thirumalai Medical Centre, Puducherry
🇮🇳Pondicherry, PONDICHERRY, India
Dr M Sakthi Balan
Principal investigator
9443627722
saheerose@gmail.com