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To assess the Skin sensitivity of Amrutanjan pain balm

A Cross over, Double blinded, Interventional study to evaluate the skin sensitivity, safety and tolerability of two types of Amrutanjan Pain Balm in healthy subjects

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/051035
Enrollment
12
Registered
2023-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Amrutanjan Health Care Limited, Tamil Nadu, India.
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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. User perception will be assessed with a 5- point Likert Satisfaction scale on the following points: 1. Ease of application, 2. Stickiness 3. Greasiness and 4. Ease of spreading. To monitor for any adverse events during the study period. Timepoint: Time frame: 0-8 hrs post dose—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

knowledge centre for innovation, integrity and implementation

saheerose@gmail.com9443627700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026