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CTRI Number  CTRI/2021/09/036928 [Registered on: 28/09/2021] Trial Registered Prospectively
Last Modified On: 14/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ayurvedic Proprietary Medicine]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Hair Benefit Study For The Test Products  
Scientific Title of Study   To evaluate the Anti-dandruff efficacy of test products in healthy Indian human  
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
HAIR/HUAD/2021-25_01 Version 1.0 Dated 07 Sep 21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidya Kuntoji 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  vidya@mscr.in  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director- Business and Operation 
Affiliation  MS Clinical Research Pvt Ltd 
Address  Room no.2, Ground floor,327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  ritambhara@mscr.in  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  Study Manager 
Affiliation  MS Clinical Research Pvt Ltd 
Address  First Floor, Room no. 1, Councelling Area, 327/15, 1st main road, cambridge layout,

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  sudhan@mscr.in  
 
Source of Monetary or Material Support  
Unilever Industries (P) Ltd 
 
Primary Sponsor  
Name  Unilever Industries Pvt Ltd 
Address  Unilever Industries (P) Ltd Research Center Stores B.D Sawant Marg, Chakala Andheri (East) Mumbai – 400099, India  
Type of Sponsor  Other [FMCG(Fast moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidya Kuntoji  MS Clinical Research Pvt. Ltd.  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934
08040917253
vidya@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  Dharunaka 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Thrice a week for 4 weeks, Ritucarya: , Acara Rasayana:, Other:Test product 1-MC44, Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmLifestyle--Dinacarya: Thrice a week for 4 weeks, Ritucarya: , Acara Rasayana:, Other:Test product 2-NR88, Pathya/Apathya:no, Pathya:, Apathya:
3Intervention ArmLifestyle--Dinacarya: Thrice a week for 4 weeks, Ritucarya: , Acara Rasayana:, Other:Test product 3-AZ50, Pathya/Apathya:no, Pathya:, Apathya:
4Intervention ArmLifestyle--Dinacarya: Thrice a week for 4 weeks, Ritucarya: , Acara Rasayana:, Other:Test product 4-OC35, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  42.00 Year(s)
Gender  Both 
Details  1.Female and male subjects in the ratio of 2:1 in general good health.
2.Subjects in the age group 18-42 years (both the ages inclusive).
3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
4.Subjects willing to abide by and comply with the study protocol.
5.Subjects who have not participated in a similar investigation in the past three months.
6.Subjects who agree to refrain from using hair dye / hair colour /henna during the study period.
7.Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration
8.Subjects who agree not to change their regular regimen (including hair oils) 
 
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 judgement.
3.Subjects (male) having androgenic alopecia, male pattern baldness’ not be included in study.
4.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.
5.Subjects (females) who are pregnant or lactating
6.Subjects who have had hair transplant.
7.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
8.Chronic illness which may influence the cutaneous state.
9.Subjects participating in other similar cosmetic or therapeutic trial within last three months
10.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
11.Subjects (males) who are having androgenic alopecia, male pattern baldness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in dandruff condition by expert/dermatologist assessment   4 weeks product and 2 weeks regression 
 
Secondary Outcome  
Outcome  TimePoints 
Significant reduction and prevention of dandruff associated conditions by expert/dermatologist assessment   4 weeks product and 2 weeks regression 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "207"
Final Enrollment numbers achieved (India)="207" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/10/2021 
Date of Study Completion (India) 18/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study will be conducted to assess the efficacy of test product in imparting hair dandruff benefits. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Post baseline assessments, test product will be dispensed to subjects as per randomization and subjects will be instructed to use the product thrice a week and evaluation assessments will be done at different times points over a period of 6 weeks.  
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