CTRI

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CTRI Number

CTRI/2022/04/041714 [Registered on: 07/04/2022] Trial Registered Prospectively

Last Modified On:

28/03/2022

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Efficacy of medicated herbal oils in hair fall management

Scientific Title of Study

A Comparative clinical study to evaluate the efficacy of Guduchi taila by Aaditypaka and Agnipaka method in hair fall (Khalitya)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Anku Bala
Designation	MD Scholar Dravyaguna Dept NIA Jaipur
Affiliation	National Institute of Ayurveda deemed to be university Jaipur
Address	Dravyaguna dept room no 137 National Isntitute of Ayurveda deemed to be university Jorawar singh gate Amer road Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	9460114337
Fax	0
Email	dr.anku.kandara1988@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Mita Kotecha
Designation	HOD Dravyaguna department
Affiliation	National Institute of Ayurveda deemed to be university Jaipur
Address	Dravyaguna department room no 133 National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	9414078872
Fax	0
Email	mita@ayu.in

Details of Contact Person
Public Query

Name	Dr Anku Bala
Designation	MD Scholar Dravyaguna Dept NIA Jaipur
Affiliation	National Institute of Ayurveda deemed to be university Jaipur
Address	Dravyaguna department room no 137 National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	9460114337
Fax	0
Email	dr.anku.kandara1988@gmail.com

Source of Monetary or Material Support

National Institute of Ayurveda deemed to be university Jaipur

Primary Sponsor

Name	National Institute of Ayurveda deemed to be university
Address	Jorawar singh gate Amer road Jaipur Rajasthan 302002
Type of Sponsor	Research institution and hospital

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 Anku Bala	National Institute of Ayurveda deemed to be university	Dravyaguna department National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan Jaipur RAJASTHAN	9460114337 0 dr.anku.kandara1988@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee of National Institute of Ayurveda deemed to be university	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L659\|\|Nonscarring hair loss, unspecified. Ayurveda Condition: khalityam,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Guduchyadi taila, Reference: chakrdutta 55/107, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Group A- No. of patients 30 Aaditypaka guduchi taila for shiroabhyanga is given. Shiroabhyanga with oil given 2 times in a week. duration of shiroabhyanga 400 matrakala (2-3 minutes). Trial given for 60 days. Follow up will be done at 30th and 60th day. Group B- No. of patients 30 Ag

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	1. Patients of age group between 18 to 40 years of either sex. 2. Patients with the classical features of Khalitya (Hair fall) since one month or more.

ExclusionCriteria

Details

1. Patients below 18 years and above 40 years.
2. Patients who have disease like Indralupta (Alopecia totalis), Tinea capitis hair fall due to chemotherapy.
3. Patients who have any uncontrolled systematic disease.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To compare the efficacy of Aaditypaka and Agnipakaguduchi taila after intervention. Subjective Parameter Hair fall(Khalitya) Kesha rukshan Kandu Keshbhumi daha Keshbhumi sweda Keshagra daaran Objective Parameters Hb gm% Serum protein Hair pull test Hairline measurement 60 seconds Hair fall test	60 Days

Secondary Outcome

Outcome	TimePoints
To assess the efficacy of Guduchi taila in hair fall with parameters such as- Kesha rukshan Kandu Keshbhumi daha Keshbhumi sweda Keshagra daaran Hair pull test Hairline measurement 60 seconds Hair fall test	60 Days

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

Date of First Enrollment (India)

01/06/2022

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Introduction

Ayurveda is considered oldest healing science. In Sanskrit, Ayurveda means The Science of life. Ayurveda is often called the Mother of all healing. It is a deep ocean of knowledge in which, not only systematic diseases but also local minor diseases are described in detail with its various effective medicine and formulations.

The concept of beauty along with skin and hair is gaining more and more attention globally. Hair is an important part of body and plays important role in appearance of individual.

Healthy, long and vibrant hairs are result of a healthy lifestyle and healthy body. Therefore, keeping hair in a healthy state is very essential nowadays for everyone, because just like the face, hair is also a mirror of a healthy state of body.

Ayurveda mentions that human body is made up of main seven Dhatus (Body elements) viz. Rasa, Rakta, Mammsa, Meda, Asthi, Majja, and Shukra. Majority of Acharyas belief that the production of later dhatu occurs from former dhatu by the function of their respective agni. The rasagni turns the ahara rasa into rasa dhatu then raktagni converts part of Rasa dhatu in Rakta and so on. Along with production of later dhatu, there is side by side production of upadhatu &mala of former dhatu.

During this process of production of dhatus when metabolism of asthi dhatu occurs by its own agni &majja dhatu emerges from sara part and at the same time hair of scalp & body and nails form as mala . According to Acharya Sharngadhar, Scalp and body hair are the upadhatu of Majja dhatu.¹

In current scenario Disorders like hair fall are commonest among young adults, Acharaya charaka has included it in shirogatrog and Acharaya sushurta, chakradutt, sharangdhar etc. have mentioned it in kshudrroga.

There are numerous herbs available naturally having different uses in cosmetic preparations for hair care. Several types of oils and lepa for abhyang and herbal medicated nasya pay essential role to improve the blood circulation and increasing the nutrition of the hair roots & scalp.

Ample of keshya drugs and formulations are mentioned in Ayurveda for external as well as internal use. Aaditypaka Guduchi taila is a herbal formulation containing Vata (Ficus bengalensis), Jatamansi (Nordostachys jatamansi), Guduchi (Tinosporacordifolia) and Tila taila (Sesamum indicum). It is economical and eco-friendly formulation for management of hair fall. In the Ayurveda samhita it is said to be made in sunlight and its good effects is told in hair problems. In this research study it will be made by Aaditypaka and Agnipaka method and their efficacy will be compared in hair fall.