CTRI

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CTRI Number

CTRI/2025/04/085097 [Registered on: 17/04/2025] Trial Registered Prospectively

Last Modified On:

16/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparing two forms of Neelikadya oil and cream to treat premature greying of hair along with analytical study

Scientific Title of Study

A Pharmaceutico-analytical and Clinical evaluation of Neelikadya taila and its conversion to cream in Akala Palitya

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 Arpitha M S
Designation	PG Scholar
Affiliation	A L N Rao Memorial Ayurvedic Medical College
Address	Department of Rasashastra and Bhaishajya kalpana A L N Rao Memorial Ayurvedic Medical College, Kachkal road Koppa Chikmagalur Karnataka 577126 India Chikmagalur KARNATAKA 577126 India
Phone	8296543458
Fax
Email	appums1999@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Dinesh Kumar Mishra
Designation	Professor
Affiliation	A L N Rao Memorial Ayurvedic Medical College
Address	Department of Rasashastra and Bhaishajya kalpana A L N Rao Memorial Ayurvedic Medical College, Kachkal road Koppa Chikmagalur Karnataka 577126 India Chikmagalur KARNATAKA 577126 India
Phone	9448744577
Fax
Email	drdkmishra12@gmail.com

Details of Contact Person
Public Query

Name	Dr Arpitha M S
Designation	PG Scholar
Affiliation	A L N Rao Memorial Ayurvedic Medical College
Address	Department of Rasashastra and Bhaishajya kalpana A L N Rao Memorial Ayurvedic Medical College, Kachkal road Koppa Chikmagalur Karnataka 577126 India KARNATAKA 577126 India
Phone	8296543458
Fax
Email	appums1999@gmail.com

Source of Monetary or Material Support

Department of Rasashastra and Bhaishajya kalpana, ALN Rao Memorial Ayurvedic Medical College,Koppa, Chikamagaluru , Karnataka 577126

Primary Sponsor

Name	Dr Arpitha M S
Address	Department of Rasashastra and Bhaishajya kalpana A L N Rao Memorial Ayurvedic Medical College Kachkal road Koppa Chikmagalur Karnataka 577126 India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Arpitha M S	ALN Rao Memorial Ayurvedic Medical College and Hospital Kachkal road, Koppa	Rasashastra and Bhaishajya kalpana ,Devision A,room no 1 ,ALN Rao Memorial Ayurvedic Medical College and Hospital Katchkal road koppa Chikamagaluru Karnataka Chikmagalur KARNATAKA	8296543458 appums1999@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
ALN Rao Memorial Ayurvedic Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L99\|\|Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: AKALAPALITAH/PALITAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Neelikadya taila, Reference: Sharanagdhara samhita, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Neelikadya cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	17.00 Year(s)
Age To	34.00 Year(s)
Gender	Both
Details	1.Patient who has clinical features of akala palitya 2.Patients within age group of 17 to 34 years. 3.Patients with irrespective of sex , occupation and religion.

ExclusionCriteria

Details

1.Heriditary diseases like albinism,vitiligo.
2.Subjects with other systemic disorders.
3.Subjects above 34 years and below 17 years

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.Color of the hair 2.Dry split hair 3.Oiliness 4.Burning sensation of scalp 5.Number of gray hairs	30 days

Secondary Outcome

Outcome	TimePoints
Not applicable	Not applicable

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3

Date of First Enrollment (India)

19/05/2025

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="0"
Days="30"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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 is a pharmaceutico analytical and clinical evaluation of Neelikadya taila and its conversion to cream for 30 days.This study comprise of two groups of 30 subjects with Akala palitya.Study will be conducted in ALN Rao Memorial Ayurvedic Hospital in Koppa taluk,Chikamagaluru district, Karnataka 577126.Primary outcome measures will be color of the hair,dry split hair ,Oiliness,Burning sensation of Scalp,Number of gray hairs.