To check safety of test products for skin irritation

Evaluation Of Irritation Potential Of Vanaura Organics Dermatological Products (Thailam, Keram, Shampoo, Conditioner, Foot Scrub, Lip Balm, Serum) Through Dermatological Evaluation By Single Occlusive Patch Test On Healthy Adult Human Volunteers - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094123

Enrollment

Registered

2025-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

None listed

Interventions

Intervention1: Vanaura Organics Nalpamaradi Thailam: Nalpamara, Thriphala, agaru, Usheera, kushta, Manjishta, Sugandhamoola, Rakta Chandana, Parpataka juice, Haridra juice, Sesame oil Intervention2: V

Eligibility

Inclusion criteria

Inclusion criteria: Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar) Age group of 18 to 55 years, 12 male and 12 female subjects. Compliance with the study procedures involved

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women 2. Subjects with any other skin disorders. 3. Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.

Design outcomes

Primary

Measure	Time frame
Outcome 1. Erythema, dryness, wrinkles Oedema 2. Mean Irritation Index Scoring System 3. Mean scores for erythema, dryness, wrinkles, and oedema will be calculated for T1, T2, and T8 days using Microsoft Excel 2010 and GraphPad Prism software. 4. Scores will be assessed for the test sample (Vanaura Organics Products) and controls (including 1% sodium lauryl sulfate).Timepoint: Screening T0 (Before Patch Application) T1 (0 Hours Post-Patch Removal) T2 (24 Hours Post-Patch Removal) T8 (1 Week Post-Patch Removal)	—

Measure

Time frame

Outcome 1. Erythema, dryness, wrinkles Oedema 2. Mean Irritation Index Scoring System 3. Mean scores for erythema, dryness, wrinkles, and oedema will be calculated for T1, T2, and T8 days using Microsoft Excel 2010 and GraphPad Prism software. 4. Scores will be assessed for the test sample (Vanaura Organics Products) and controls (including 1% sodium lauryl sulfate).Timepoint: Screening T0 (Before Patch Application) T1 (0 Hours Post-Patch Removal) T2 (24 Hours Post-Patch Removal) T8 (1 Week Post-Patch Removal)

—

Secondary

Measure	Time frame
Adverse event monitoringTimepoint: Screening T0 (Before Patch Application) T1 (0 Hours Post-Patch Removal) T2 (24 Hours Post-Patch Removal) T8 (1 Week Post-Patch Removal)	—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

DK Elite Health Care Centre

saheerose@gmail.com9443627722

Outcome results