| CTRI Number |
CTRI/2025/11/098109 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Find Out The Effect of Amrutveni LiceQit shampoo in Managing Head Lice Infestation |
|
Scientific Title of Study
|
A
prospective, open-label, single-arut interventional clinical test to evaluate the effectiveness of Amrutveni Liceeit shampoo in the management of head lice infestation |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Hareendran Nair |
| Designation |
Managing Director |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No1 Department of R&D Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
09447096201 |
| 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
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
Thiruvananthapuram
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,
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: B85||Pediculosis and phthiriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrutveni LiceQit Shampoo |
Type of Product: Herbal topical formulation (cosmeceutical / therapeutic shampoo) Dosage Form: shampoo (for external application on scalp and hair) Route of Administration: Topical (scalp and hair application) Dosage / Frequency / Duration: Approximately 5–12 mL of Amrutveni LiceQit shampoo will be applied uniformly over the scalp and hair, ensuring complete coverage from roots to tips. The procedure will be repeated once daily for 7 days, followed by reassessment on Days 14, 21. |
| Comparator Agent |
na |
na |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 10 and 55 years
Presence of head Lice infestation |
|
| ExclusionCriteria |
| Details |
Known allergy or hypersensitivity to any of the ingredients in Amrutveni LiceQit Shampoo
Active scalp conditions such as psoriasis, seborrheic dermatitis, eczema, or open scalp wounds
Use of any pediculicidal treatment within the preceding 7 days
Participation in any other interventional clinical study within the last 30 days
Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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, |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/12/2025 |
| 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 shampoo 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. 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 shampoo as a safe herbal anti-lice formulation. |