| CTRI Number |
CTRI/2025/10/096413 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate How Effectively Amrutveni LiceQit Oil Treats Head Lice Infestation in Children and Adults. |
|
Scientific Title of Study
|
An Open-Label, Single-Arm, Interventional Clinical Test to Evaluate the Efficacy of Amrutveni LiceQit oil in Reducing Head Lice and Nit Count |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/PKHRF/103/10-25 Version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Hareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No1 Department of E&D Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
hareendrannair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kasthuri Nair A |
| Designation |
Director |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
| Address |
Room No 1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy
Thiruvananthapuram
KERALA
695572
India |
| Phone |
8113851665 |
| Fax |
|
| Email |
dr.kasthurinair@pkhil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kasthuri Nair A |
| Designation |
Director |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre |
| Address |
Room No 1 Department of kayachikitsa Pankajakasthuri Ayurveda Medical college and PG centre Killy
KERALA
695572
India |
| Phone |
8113851665 |
| Fax |
|
| Email |
dr.kasthurinair@pkhil.com |
|
|
Source of Monetary or Material Support
|
| Sahyadri Bio Labs Pvt. Ltd.
V/277, Pannissery, Koonamoochi P.O
Thrissur Dt PIN - 680504 |
|
|
Primary Sponsor
|
| Name |
Sahyadri Bio Labs Pvt. Ltd |
| Address |
V/277, Pannissery, Koonamoochi P.O Thrissur Dt PIN - 680504 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aswathy R S |
Pankajakasthuri Ayurveda Medical college and PG centre |
Room No 2 Department of Swasthavritha, Pankajakasthuri Ayurveda Medical college and PG centre
Thiruvananthapuram
KERALA |
9496185896
aswathyrsb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B850||Pediculosis due to Pediculus humanus capitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrutveni LiceQit oil |
Type of Product:
Herbal topical formulation (cosmeceutical / therapeutic oil)
Dosage Form:
Oil (for external application on scalp and hair)
Route of Administration:
Topical (scalp and hair application)
Dosage / Frequency / Duration:
Approximately 10–15 mL of Amrutveni LiceQit Oil will be applied uniformly over the scalp and hair, ensuring complete coverage from roots to tips. The oil will be left in place for 45 minutes and then rinsed off using mild shampoo and water. The procedure will be repeated once daily for 7 days, followed by reassessment on Days 14, 21, and 28. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 18 and 60 years
Presence of head Lice infestation |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
Day 0 (baseline), Day 1–7, Day 14, Day 21, and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Pediculosis Severity Score (PSS) from Day 0 to Day 28.
2. Change in itching intensity (VAS, 0–10).
3. Change in scalp inflammation/redness (0–3 scale).
4. Improvement in hair texture, softness, and manageability.
5. Change in hair volume and tangle score.
6. Overall subject satisfaction (1–5 Likert scale).
7. Incidence of local irritation, erythema, allergic reaction, and overall safety (IGDES score).
|
Day 0 (baseline), Day 1–7, Day 14, Day 21, and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |