CTRI

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CTRI Number

CTRI/2026/02/105039 [Registered on: 27/02/2026] Trial Registered Prospectively

Last Modified On:

27/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A randomized controlled clinical trial to evaluate the efficacy of Prachchhanna Karma followed by Shirabhyanga with Neelini Taila in the management of Androgenetic Alopecia and Alopecia Areata

Scientific Title of Study

A Randomized Controlled Clinical Trial to Assess the Therapeutic Efficacy of Prachchhanna Karma Followed by Shirabhyanga with Neelini Taila in Androgenetic Alopecia and Alopecia Areata

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 Nilam Tadvi
Designation	Pg scholar
Affiliation	Parul institute of Ayurveda
Address	Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University Limda Vadodara India Vadodara GUJARAT 391760 India
Phone	9328763313
Fax
Email	tadvihelly315@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Hemant Toshikhane
Designation	Dean
Affiliation	Parul institute of Ayurveda
Address	Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University Limda Vadodara GUJARAT 391760 India Vadodara GUJARAT 391760 India
Phone	8469496525
Fax
Email	hemant.toshikhane@paruluniversity.ac.in

Details of Contact Person
Public Query

Name	Dr Hemant Toshikhane
Designation	Dean
Affiliation	Parul institute of Ayurveda
Address	Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University Limda Vadodara GUJARAT 391760 India Vadodara GUJARAT 391760 India
Phone	8469496525
Fax
Email	hemant.toshikhane@paruluniversity.ac.in

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Parul institute of Ayurveda
Address	Parul Institute of Ayurved Department of Shalya Tantra 4th floor room no 403 Parul University Limda Vadodara GUJARAT 391760 India
Type of Sponsor	Private medical college

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 Hemant Toshikhane	Parul ayurveda hospital	Parul University Limda Waghodia 391760 Vadodara Vadodara GUJARAT	8469496525 hemant.toshikhane@paruluniversity.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Parul institute of Ayurveda	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L640\|\|Drug-induced androgenic alopecia. Ayurveda Condition: KHALITYAM/KHALATI, (2) ICD-10 Condition:L648\|\|Other androgenic alopecia. Ayurveda Condition: KHALITYAM/KHALATI,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	pracCAnam, प्रच्छानम्	(Procedure Reference: Sushrut samhita , Procedure details: Prachchhanna Karma performed over affected scalp area using sterile sharp instrument as per Sushruta Samhita. Controlled superficial incisions made till capillary oozing occurs. After hemostasis, Shirabhyanga performed using Neelini Taila for 20 minutes. Procedure repeated once weekly for 8 weeks.)
2	Comparator Arm	Procedure	-	Shirabhyanga with Neelini taila	(Procedure Reference: Sharangdhara samhita , Procedure details: Shirabhyanga with Neelini taila after prachana karma use daily 2-3 ml)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	• Age 18–45 years • Clinically diagnosed Androgenetic Alopecia (Grade I–III) or Alopecia Areata • Willingness to participate and provide written informed consent • Fit for Prachchhanna Karma procedure

ExclusionCriteria

Details

• Scalp infections or dermatological disorders other than alopecia
• Systemic autoimmune diseases
• Uncontrolled diabetes mellitus or hypertension
• Bleeding disorders
• Pregnant or lactating women
• History of scalp surgery or hair transplantation
• Known hypersensitivity to Neelini Taila

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Hair Count, Hair density, Hair Pull test, SALT score	Baseline and after completion of treatment ( 8 weeks)

Secondary Outcome

Outcome	TimePoints
Patient Satisfaction score, Photographic assessment, Reduction in hair fall	Total sample size 40

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

10/03/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

10/03/2026

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="2"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

Study Title: A Randomized Controlled Clinical Trial of Prachchhanna Karma Followed by

Shiroabhayanga with Neelini Taila in the Management of Androgenetic Alopecia and Alopecia

Areata

Introduction

Hair loss, also known as Khalitya or alopecia, is a complex condition influenced by genetics,

lifestyle, and autoimmune factors. The study focuses on two main types:

According to the Sushruta Samhita, a classical Ayurvedic text, hair loss occurs when Kapha blocks

hair roots, and Vata and Pitta destroy them. This study aims to address the root cause of hair loss

using traditional Ayurvedic methods, which are seen as a holistic, long-term alternative to

conventional treatments.

Need for the Study

Despite traditional support for Ayurvedic treatments, there’s a lack of scientific research on the

combined approach of Panchkarma and Neelini for hair disorders. With the rising prevalence of hair

loss due to lifestyle and stress, and the limitations of conventional treatments, there’s a growing

demand for natural, side-effect-free options. This study seeks to provide scientific validation for

these traditional methods.

Methodology

The study is designed as a randomized controlled clinical trial with a sample size of 40 participants.

The total duration of the study is projected to be 18 to 24 months, with a treatment period of two

months and a follow-up after two months of treatment.

Interventions

The treatment protocol involves two key Ayurvedic procedures:

Prachchhanna Karma: A procedure involving the letting out of blood using a sharp instrument.

According to Sushruta, this involves making superficial, straight-line scratches that are not too deep

or too shallow. This technique is believed to improve scalp vascularity and reduce vitiated Rakta

(blood).

Shiroabhayanga with Neelini Taila: This involves a head massage using a medicated oil called

Neelini Taila. This is intended to nourish the scalp and promote hair growth. The oil’s ingredients

include Neeli, Bhringaraja, Yashtimadhu, and others, which will be procured and analyzed at the

Parul Ayurveda Pharmacy.

Data Collection and Assessment

Data will be collected using both subjective and objective criteria