CTRI

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CTRI Number

CTRI/2023/01/048717 [Registered on: 03/01/2023] Trial Registered Prospectively

Last Modified On:

20/02/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Efficacy of Ayurvedic hair oil formulations in self perceived hair thinning and hair loss.

Scientific Title of Study

Efficacy and safety study of Ayurvedic hair oil formulations in healthy volunteers with self perceived hair thinning and hair loss.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIA-BVG Hair loss version 3 dated 28/09/22	Protocol Number

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

Name	DrKshipra Rajoria
Designation	Assistant Professor
Affiliation	National Institute of Ayurveda,Jaipur
Address	Room no.115C, Department of postgraduate studies in Panchakarma, National Institute of Ayurveda, Jaipur Jaipur RAJASTHAN 302002 India
Phone	9001454100
Fax
Email	kshiprarajoria@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sarvesh Kumar Singh
Designation	Associate professor
Affiliation	National Institute of Ayurveda,Jaipur
Address	Room no.113A,Department of postgraduate studies in Panchakarma, National Institute of Ayurveda, Jaipur Jaipur RAJASTHAN 302002 India
Phone	8739860237
Fax
Email	sarveshksingh21@gmail.com

Details of Contact Person
Public Query

Name	Dr Sarvesh Kumar Singh
Designation	Associate professor
Affiliation	National Institute of Ayurveda,Jaipur
Address	Room no.113A,Department of postgraduate studies in Panchakarma, National Institute of Ayurveda, Jaipur Jaipur RAJASTHAN 302002 India
Phone	8739860237
Fax
Email	sarveshksingh21@gmail.com

Source of Monetary or Material Support

BVG life Sciences Limited

Primary Sponsor

Name	BVG life Sciences Limited
Address	Sagar Complex, Nashik Phata, Opposite Kasarwadi Railway Station, Pune 411 034
Type of Sponsor	Pharmaceutical industry-Indian

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 Kshipra Rajoria	National Institute of Ayurveda hospital	Room no.115C,Department of Panchakarma, National Institute of Ayurveda, Amer road Jorawar Singh gate Jaipur Jaipur RAJASTHAN	9001454100 kshiprarajoria@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA	Approved
Institutional ethics committee National Institute Of Ayurveda Jaipur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L649\|\|Androgenic alopecia, unspecified. Ayurveda Condition: KHALITYAM/KHALATI,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: HO-0, Reference: Bhavprakash nighantu, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Participants will be instructed for topical application of hair oil on scalp and hair twice a week (with atleast two days gap between) at night
2	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: HO-2, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Participants will be instructed for topical application of hair oil on scalp and hair twice a week (with atleast two days gap between) at night
3	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: HO-1, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Participants will be instructed for topical application of hair oil on scalp and hair twice a week (with atleast two days gap between) at night
4	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: HO-3, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Participants will be instructed for topical application of hair oil on scalp and hair twice a week (with atleast two days gap between) at night

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Willing to provide voluntary written informed consent 2.Patients having selfreported thinning or hair loss for more than 6 months prior to screening 3.Patient clinically confirmed to have hair loss or thinning though physical exam for female pattern hair loss Savin Classification score of I 2 TO II 1for male pattern hair loss NorwoodHamilton classification score I AND II AND III 3.Patient willing to maintain same hair style hair color and hair regimen throughout the study and use mild non medicated shampoo during the study period 4.Women of child bearing age willing to adopt medically sound method of birth control during the trial period

ExclusionCriteria

Details

1. Clinical diagnosis of alopecia areata or scarring forms of alopecia or hair loss due to disease injury or medical therapy
2. Patient hypersensitive to study product or hair dye and its component.
3. History of hair transplant.
4.Patients with diagnosed organic disease of scalp with dermatological origin (other than mild to moderate dandruff determined by Adherent Scalp Flaking Score) like psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis which requires medication.
5.Pregnant or lactating women
6.Diagnosis of organic diseases including Uncontrolled diabetes mellitus (DM), endocrinal disorder, Hypertension, neoplastic, severe cardiovascular diseases, renal insufficiency, psychiatric disorders, iron deficiency, coagulopathies etc or on any medication that can cause potential hair loss or affects hair growth.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome

Outcome	TimePoints
Evaluate changes in hair density	Time Frame Baseline to Week 12and week 16

Secondary Outcome

Outcome

TimePoints

To analyze changes in the number of hair loss in comb test and pull test, subjective assessment of hair health variables through Modified Self-assessment questionnaire, effect on dandruff through Adherent Scalp Flaking Score (ASFS), acceptability of hair oil formulation though modified topical product usability questionnaire, Safety will be assessed at all visits through vital signs and scalp evaluations for symptoms of irritation and self observed and reported Adverse events (AEs).

Time Frame Baseline to Week 12and week 16

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120"

Phase of Trial

Phase 3

Date of First Enrollment (India)

09/01/2023

Date of Study Completion (India)

02/10/2023

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="9"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

not applicable

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

The present work is undertaken to assess the efficacy and safety of hair oil formulations in healthy volunteers with self-perceived hair thinning and hair loss. It was a twelve-week study with four weeks of follow-up. The study population was 120 healthy volunteers randomly divided into four equal groups of 30 individuals. Group HO - 1, Group HO - 2, Group HO - 3 was the interventional group, and Group HO - 0 was the comparator group. Hair oil formulations were topically administered. The primary outcome of the study was to analyze changes in hair density from Baseline to Week 12 and week 16 and the secondary outcomes was to analyze changes in the number of hair loss in comb test and pull test, subjective assessment of hair health variables through Modified Self-assessment questionnaire, effect on dandruff through Adherent Scalp Flaking Score (ASFS), acceptability of hair oil formulation though modified topical product usability questionnaire and collecting information regarding self observed and reported Adverse events (AEs).