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CTRI Number  CTRI/2025/02/081312 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Bamboo Towels]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Evaluate the Effect of Mrithu Bamboo Towel in Healthy Paricipants 
Scientific Title of Study   Open label, comparative, proof of concept study to evaluate the effectiveness of Mrithu bamboo towel, in the process of cleaning, level of comfort and preventing bacterial and fungal skin infections in healthy participants. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BAMBOOTOWEL /01/25, Version No 1.0 Dated: 04-01-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakthi Balan MBBS MD 
Designation  Consultant 
Affiliation  DK Elite Health Care Centre 
Address  Room No 2, 370, First Floor, Cuddalore Main Road, Nainar Mandapam, Velrampet, Puducherry, 605004

Pondicherry
PONDICHERRY
605004
India 
Phone  09843591097  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sakthi Balan MBBS MD 
Designation  Consultant 
Affiliation  DK Elite Health Care Centre 
Address  Room No 2, 370, First Floor, Cuddalore Main Road, Nainar Mandapam, Velrampet, Puducherry, 605004

Pondicherry
PONDICHERRY
605004
India 
Phone  09843591097  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar 
Designation  Director 
Affiliation  KI3 PRIVATE LIMITED 
Address  No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai

Chennai
TAMIL NADU
600 044
India 
Phone  09003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
ENES TEXTILE MILLS, No 9, Sengynthapuram, 1st street, Karuvampalayam, Tirupur-641604, Tamil nadu, India 
 
Primary Sponsor  
Name  ENES TEXTILE MILLS 
Address  No:9, Sengunthapuram, 1st Street, Karuvampalayam, Tirupur - 641604, Tamil Nadu, India 
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 Sakthi Balan  DK Elite Health Care Centre  Room No 1, No.370, First Floor, Cuddalore Main Road, Nainarmandapam, Puducherry-605 004
Pondicherry
PONDICHERRY 		 09443627722

saheerose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHIQUE DE LA NATURE ASSOCIATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  General Hygiene 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal cotton turkey towels  Daily usage as required– for a period of 28 days 
Intervention  Regenerated Cellulose Fibre (Bamboo)  After taking a bath, gently pat or wipe the skin dry for 28 Days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age group between 18 to 70 years, inclusive of equal proportion of male and female healthy participants.
2. Availability of participant for the entire study period and willing to adhere to protocol requirements as evidenced by the written ICF duly signed by the volunteer.
3. Participants with no evidence of life-threatening disease based on screening, medical history and physical examination within 28 days prior to the commencement of the study
4. Participants, who are willing to avoid sun bathing, swimming, prolonged sun exposure or artificial ultra-violet rays during the course of the study.
 
 
ExclusionCriteria 
Details  1. Participants with history of allergies.
2. Participants who have fungal or bacterial skin infection, sunburned, chapped, or irritated skin or open wounds on test sites (Axilla, neck, hip and groin region).
3. Participants who have an underlying immunosuppressive condition 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. A swab for bacterial and fungal analysis of the skin will be collected at baseline and again after 4 weeks of use, from one of the following areas: neck, axilla, hip, or groin.
2. The occurrence of any bacterial (including normal skin commensals and Staphylococcus) and fungal skin infections, as well as skin irritations, allergic reactions, prickly heat, rashes, and itching, will be monitored throughout the 4-week study period.
3. The user perceptions and feedback on softness, absorption of sweat, prevention of bad odor and comfortability will be assessed from baseline and up to 4 weeks.
4. Random samples of the towels (2 tests and 2 comparators) will be sent to the South India Textile Research Association (SITRA) for bacterial and fungal bioburden at the end of 4 weeks of study.
 		 Day 0 and end of week 4 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor for any adverse events during the study period
 		 Day 0 and end of week 4 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   10/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

24 participants who fulfilled the inclusion and exclusion criteria will be enrolled randomized into two groups.

1.     Arm 1: Healthy participants using bamboo towels (n=12)

2.      Arm 2: Healthy participants using standard cotton turkey towels (n=12)

·       Usage benefits of Mrithu bamboo towel will be explained during counselling and handed over to be used daily, after their bath

·       Participants will be asked to air dry the towel or wash the towel after body wiping procedure

·       Subject will be given subject diary to ensure every day usage

·       At the end of the 4th week of usage, piece of the towel material will be sent to ‘The SITRA’ for bacterial and fungal bioburden analysis.


Primary outcomes

1.     A swab for bacterial and fungal analysis of the skin will be collected at baseline and again after 4 weeks of use, from one of the following areas: neck, axilla, hip, or groin. [Time frame: Day 0 and end of week 4]

2.     The occurrence of any bacterial (including normal skin commensals and Staphylococcus) and fungal skin infections, as well as skin irritations, allergic reactions, prickly heat, rashes, and itching, will be monitored throughout the 4-week study period.

3.     The user perceptions and feedback on softness, absorption of sweat, prevention of bad odor and comfortability will be assessed from baseline and up to 4 weeks.

4.     Random samples of the towels (2 tests and 2 comparators) will be sent to the South India Textile Research Association (SITRA) for bacterial and fungal bioburden at the end of 4 weeks of study.

 

 


 
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