An Open-Label, Single-Arm, Interventional Clinical Test to Evaluate the Efficacy of Amrutveni LiceQit oil in Reducing Head Lice and Nit Count
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sahyadri Bio Labs Pvt. Ltd
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Mean percentage reduction in live lice and nit count from baseline (Day 0) to Day 28, determined by standardized lice detection combing and count comparison
Overview
Brief Summary
This open-label, single-arm interventional clinical study aims to evaluate the efficacy and safety of Amrutveni LiceQit Oil in reducing head lice and nit infestation. A total of participants with clinically confirmed pediculosis will undergo baseline assessment followed by treatment and periodic evaluations on Days 1–7, 14, 21, and 28. Efficacy will be measured by percentage reduction in live lice and nit counts, improvement in itching, scalp comfort, and hair quality. Safety will be assessed through monitoring of erythema, irritation, and other local adverse reactions. The study seeks to establish Amrutveni LiceQit Oil as a safe herbal anti-lice formulation
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Individuals aged between 18 and 60 years Presence of head Lice infestation.
Exclusion Criteria
- •Known hypersensitivity or allergy to any ingredients present in the Amrutveni LiceQit Oil.
- •Presence of underlying dermatological scalp disorders such as psoriasis, seborrheic dermatitis, or eczema.
- •Use of other anti-lice treatments or pediculicides within the preceding 7 days.
- •Participation in any other clinical test within the past 30 days.
- •Pregnant or lactating women, due to unknown effects on maternal or neonatal health.
Outcomes
Primary Outcomes
Mean percentage reduction in live lice and nit count from baseline (Day 0) to Day 28, determined by standardized lice detection combing and count comparison
Time Frame: Day 0 (baseline), Day 1–7, Day 14, Day 21, and Day 28
Secondary Outcomes
- 1. Change in Pediculosis Severity Score (PSS) from Day 0 to Day 28.(2. Change in itching intensity (VAS, 0–10).)
Investigators
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation