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CTRI Number  CTRI/2020/02/023127 [Registered on: 05/02/2020] Trial Registered Prospectively
Last Modified On: 06/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical Study of Dabur Vatika Nilibringhadi Gold Hair Growth Oil in Comparison to a Marketed Comparator and “No Treatment” arm in healthy Human Volunteers 
Scientific Title of Study   Clinical Evaluation of Efficacy and Safety of Dabur Vatika Nilibringhadi Gold Hair Growth Oil in Comparison to a Marketed Comparator and “No Treatment” arm 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MSCR/DAHS/2019-04, Version 1.0, Date 06 Jan 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sapna R 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  Ground floor, Sensitivity Room, MS Clinical Research Pvt Ltd, 327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  8040917253   
Fax  8040917253   
Email  sapna.r@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Gupta 
Designation  Head Medical Affairs & Clinical Reserach 
Affiliation  Dabur India Limited 
Address  Dabur Research & Development Centre, Dabur India Ltd, Plot No.22, Site IV, Sahibabad

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9910200255  
Fax  1204552645  
Email  arun.gupta@dabur.com  
 
Details of Contact Person
Public Query  
Name  Ritambhara 
Designation  Manager- Business & Operations 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  Ground floor, Sensitivity Room, MS Clinical Research Pvt Ltd, 327/15, 1st Main Road, Cambridge Layout, Ulsoor,

Bangalore
KARNATAKA
560008
India 
Phone  8040917253  
Fax  8040917253  
Email  ritambhara@mscr.in  
 
Source of Monetary or Material Support  
Dabur India Limited 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research & Development Centre Dabur India Ltd Plot No.22 Site IV Sahibabad, Ghaziabad Uttar Pradesh India 
Type of Sponsor  Other [Healthcare & FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
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 Sapna Ramnane  MS Clinical Reserch Pvt Ltd  327/15, 1st Main Road Cambridge Layout Ulsoor
Bangalore
KARNATAKA 		 8040917253
8040917253
sapna.r@mscr.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Complaining of Hair Fall 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Marketed Hair Oil  Product will be applied on scalp thrice a week upto 45 days and asked to keep it overnight before washing with non-conditioning shampoo. 
Intervention  Dabur Vatika Nilibringhadi Gold Hair Growth Oil  Product will be applied on scalp thrice a week upto 45 days and asked to keep it overnight before washing with non-conditioning.  
Comparator Agent  Non-Conditioning Shampoo  Subject will be asked to wash their hair with non-conditioing shampoo thrice a week.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Male and female subjects’ in general good health.
2) Subjects in the age group 18-45 years (both the ages inclusive).
3) Subjects complaining of hair fall and damage.
4) Subjects willing to give a written informed consent and willing to
abide by and comply with the study protocol.
5) Hair density of >100 and <200 hair follicle per square cm as per
Trichoscan measurement
6) Male & female Subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per photo numerical10 point scale
(Linear scale for assessment purpose-In use Scale). 
 
ExclusionCriteria 
Details  1) Subjects who have undergone hair growth treatment within 3 months before screening into the study.
2) Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgment.
3) Subjects who have taken chemotherapy for cancer in the 6 months
prior to start of the study or have a plan to do treatments during study.
4) Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
5) Subjects who have had hair transplant, who have taken
pharmaceutical product which cause hirsutism (ex. phenytoin) and
finasteride for androgenic alopecia, under medical treatment for hair problems.
6) A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
7) Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour which will compromise the study.
8) Subjects who are pregnant or lactating or nursing as established with medical history 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Assessment of change in hair length
2) Assessment of change in hair growth rate 		 2, 4 & 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) Assessment of change in hair density
2) Assessment of change in anagen and telogen ratio
3) Assessment of change in density of vellus hair & terminal hair
4) Assessment of change in hair thickness and hair fall
5) Assessment of change in hair thinning by dermatologists
6) Assessment of overall safety of test product 		 2, 4 & 6 weeks 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
Final Enrollment numbers achieved (Total)= "111"
Final Enrollment numbers achieved (India)="111" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Completed Publication Details Results of the study of this clinical study may be used for publishing scientific papers and data. All the data generated on the trial will be exclusive property of sponsor; and no publication can be done without sponsor written approval 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Adult subjects of either sex with age between 18-45 years (both inclusive) will be screened for eligibility criteria. On screening visit, before starting any study procedure, written informed consent will be obtained. After that shaving of test area will be performed. The final eligibility will be confirmed with density evaluation two days after shaving (day -14). After confirming the eligibility, the subjects will be asked to use neutral shampoo thrice a week for 14 days. After two weeks of wash out period, at day 1, subject will be randomized to either of three groups i.e. Dabur Vatika Nilibringhadi Gold Hair Growth Oil, Indulekha Bringha Hair Oil and “No treatment.” arm. 
All baseline assessment like baseline dermatological assessments and imaging will be performed. This visit will also include shaving of the test area. Post baseline assessments, subjects will be provided with the test product and will be instructed to use the test product for 45 days Further, the subjects will visit the site on day 3 for the phototrichogram assessment. Follow up evaluations will be performed at day 15 & 17, day 30 ad 32 and day 45 & 47. On day 15, 30 and 45, dermatological assessments and imaging will be performed. This visit will also include shaving of the test area. Further, the subjects will visit the site on day 17, 32 and day 47 (two days’ post shaving of the test area) for the phototrichogram assessment. On day 47 (last visit) post completion of the assessments the test product and subject diary will be retrieved and study exit form will be filled up.
 
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