| CTRI Number |
CTRI/2025/10/096434 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/10/2025 |
| 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 Oil 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 The D Oil DandroQit 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 and Founder |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No1 Department of E&D Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada
Thiruvananthapuram
Thiruvananthapuram
KERALA
695573
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 |
oom 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 |
oom 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 |
/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 Aparna Chandran |
Pankajakasthuri Ayurveda Medical college and PG centre |
Room No 2 Department of Kayachikitsa, Pankajakasthuri Ayurveda Medical college and PG centre
Thiruvananthapuram
KERALA
Thiruvananthapuram
KERALA |
8075231774
aparnabs94@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: L21||Seborrheic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrutveni The D Oil DandroQit |
Type:
Topical herbal oil formulation
Dosage Form:
Oil (for external application on scalp)
Route of Administration:
Topical application on scalp
Mode of Use:
Approximately 5–10 mL of oil to be applied uniformly over the scalp and gently massaged for 3–5 minutes once daily for 21 consecutive days. The oil should remain on the scalp for at least 30 minutes before washing with a mild, non-medicated shampoo.
Dosage Regimen and Duration:
Once daily application for 21 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Adult male and female participants aged 18 to 55 years.
Clinically diagnosed cases of mild to moderate dandruff, confirmed by Flake Severity Score.
Willingness to refrain from using other topical or oral anti-dandruff agents or hair treatments during the study.
Written informed consent provided after being briefed about the study.
|
|
| ExclusionCriteria |
| Details |
Diagnosed cases of other scalp dermatoses (e.g., psoriasis, tinea capitis, seborrheic dermatitis).
History of hypersensitivity or allergic reactions to any ingredients of the study product.
Use of systemic corticosteroids, antibiotics, or antifungals within the past 4 weeks.
Participation in another clinical trial in the past 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 |
| 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 |
Change in Adherent Scalp Flaking Score (ASFS; 0–100).
Change in Pruritus intensity (VAS 0–10 cm).
Change in Flake Severity Score (FSS 0–5).
Investigator Global Assessment (IGA 0–5).
Change in Scalp Redness / Erythema grade (0–4).
Change in Scalp Acne Severity Index (SASI 0–12).
Composite Local Skin Irritation Score (LSIS 0–16).
Subject Self-Assessment Questionnaire (5-point Likert) for perceived flake reduction, itch relief, comfort, and satisfaction.
Cosmetic Outcome / Hair Health Assessment (5-point Likert) — shine, smoothness, texture, and overall hair appearance.
Hair Strand Health Assessment — investigator/photographic evaluation.
Safety outcomes: Incidence and severity of Adverse Events (AEs) and Serious AEs (SAEs) from first application.
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2025 |
| 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 Oil 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. |