| CTRI Number |
CTRI/2025/11/097275 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the safety and effectiveness of Amrutveni DandroQit shampoo in reducing dandruff and improving scalp condition in adults with mild to moderate dandruff |
|
Scientific Title of Study
|
A Single-Arm, Open-Label, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Amrutveni DandroQit shampoo in the Management of Mild to Moderate Dandruff |
| 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
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. |
| 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 Nisha M G |
Pankajakasthuri Ayurveda Medical college and PG centre |
Room No 2 Department of Roganidana, Pankajakasthuri Ayurveda Medical college and PG centre
Thiruvananthapuram
KERALA |
8301087174
nishamgmalu@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: L20-L30||Dermatitis and eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrutveni DandroQit Shampoo |
Type: Topical herbal shampoo formulation Dosage Form: shampoo (for external application on scalp) Route of Administration: Topical application on scalp Mode of Use: Approximately 5–12 mL of oil to be applied uniformly over the scalp and gently massaged for 1-2 minutes once daily for 21 consecutive days. Dosage Regimen and Duration: Once daily application for 21 days |
| Comparator Agent |
na |
na |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged 10 to 55 years.
2. Clinical diagnosis of mild to moderate dandruff, defined by a Flake Severity Score (FSS) of 1–3.
3. Willingness to abstain from using any other hair care or anti-dandruff products throughout the study duration.
4. Voluntary participation with written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Participants with other known scalp disorders (e.g., psoriasis, seborrheic dermatitis, tinea capitis).
2. Individuals with known hypersensitivity or allergy to any of the shampoo components.
3. Use of systemic corticosteroids, antifungals, or antibiotics in the past 4 weeks.
4. Participation in another clinical study in the last 30 days.
5. Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Dandruff Severity Index (DSI; 0–9, clinician-rated) from baseline (Day 0) to end of treatment (Day 21). |
Day 0 (Baseline), Days 1–7 (daily symptom/safety tracking), Day 7, Day 14, and Day 21 (end of treatment). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pruritus Assessment (VAS)
2. Subjective Hair Manageability Questionnaire
3. Wet Combability Test
4. Ocular Irritation Scale
5. Investigator Global Assessment (IGA)
6. Subject Self-Assessment Questionnaire
7. Hair Strand Health Assessment
8. Cosmetic Outcome Evaluation
|
Day 0 (Baseline), Days 1–7 (daily symptom/safety tracking), Day 7, Day 14, and Day 21 (end of treatment). |
|
|
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)
|
26/11/2025 |
| 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 evaluates the therapeutic efficacy and safety of Amrutveni
DandroQit shampoo in the management of mild to moderate dandruff. A total
of participants meeting inclusion criteria will apply the investigational oil
for 21 days. Efficacy will be assessed using clinician- and patient-reported
outcomes, including Dandruff Severity Index (DSI), Adherent Scalp Flaking Score
(ASFS), pruritus (VAS), and Investigator Global Assessment (IGA). Cosmetic and
user satisfaction outcomes will also be recorded. Safety will be monitored
through local irritation scores and adverse event reporting. The study aims to
determine clinical improvement and scalp tolerability following treatment. |