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CTRI Number  CTRI/2025/02/080015 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess the microbiome on the scalp and skin based on the dandruff and environmental factors. 
Scientific Title of Study   A microbiome profiling study on scalp and skin in response to dandruff severity and environmental stressors respectively  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MICR/MSPS/2024-01 version 1.0 dated 10 Jan 2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukta Sachdev 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd, 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore-560008, Karnataka, India

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  mukta.sachdev@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director- Business & Operation  
Affiliation  MS Clinical Research Pvt. Ltd  
Address  MS Clinical Research Pvt. Ltd, 327/15, 1st Main Road, Cambridge layout Ulsoor, Bangalore-560008, Karnataka, India

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  ritambhara@msclinical.com   
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  Manager - Techno-commercial  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  MS Clinical Research Pvt. Ltd, 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore-560008, Karnataka, India

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
MS Clinical Research Pvt. Ltd, 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore-560008, Karnataka, India 
 
Primary Sponsor  
Name  MS Clinical Research Pvt Ltd 
Address  Room no. 1, Second floor, 327/15, 1st Main Road Cambridge layout, Ulsoor Bangalore-560008, Karnataka, India 
Type of Sponsor  Contract research organization 
 
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 Mukta Sachdev   MS Clinical Research Pvt. Ltd  327/15, 1st Main Road, Cambridge layout Ulsoor, Bangalore-560008, Karnataka, India
Bangalore
KARNATAKA 		 8040917253

mukta.sachdev@msclinical.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and female participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Male and Female Subjects in the age group 18-45 years (both the ages inclusive).
2) Subjects must have no underlying medical conditions.
3) Subjects must not have experienced any fever or cough in the past 2 weeks.
4) Subjects must not have taken any antibiotics in the past 2 weeks.
5) Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.  
 
ExclusionCriteria 
Details  1) Subjects who have undergone any kind of hair growth treatment in the last 1 months
2) Subjects who work in chemical related industries or animal husbandry jobs.
3) Subjects having any active but controllable scalp disease which may interfere in the study assessments.
4) Subjects who have taken chemotherapy for cancer in the 6 months prior to the study start.
5) Subjects on oral medications like topical or systemic corticosteroids undergoing any chemical hair salon treatment straightening perming colour henna which will compromise the study.
6) Subjects who are pregnant or nursing Self declared.
7) Subjects with 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.
has context menu 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the microbiome profiles of dandruff-affected versus healthy scalps, and in groups with low and high exposure to oxidative stress (pollution and UV).  Day-2, Day 0 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   N/A 
Date of First Enrollment (India)   09/02/2025 
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="0"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This study designed for microbiome profiling and analyzing in individuals with various scalp conditions, including dandruff and healthy scalp, while also exploring the impact of oxidative stressors like pollution and UV exposure.

 
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