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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

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 - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096434
Enrollment
36
Registered
2025-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L21- Seborrheic dermatitis

Interventions

Intervention1: 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 Us

Sponsors

Sahyadri Bio Labs Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change in Dandruff Severity Index (DSI; 0–9, clinician-rated) from baseline (Day 0) to end of treatment (Day 21).Timepoint: Day 0 (Baseline), Days 1–7 (daily symptom/safety tracking), Day 7, Day 14, and Day 21 (end of treatment).—

Secondary

MeasureTime frame
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. Timepoint: Day 0 (Baseline), Days 1–7 (daily symptom/safety tracking), Day 7, Day 14, and Day 21 (end of treatment).—

Countries

India

Contacts

Public ContactDr Kasthuri Nair A

Pankajakasthuri Ayurveda Medical college and PG centre

dr.kasthurinair@pkhil.com8113851665

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026