To Evaluate the Effect of Mrithu Bamboo Towel in Healthy Paricipants
- Conditions
- General Hygiene
- Registration Number
- CTRI/2025/02/081312
- Lead Sponsor
- ENES TEXTILE MILLS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 24
- Age group between 18 to 70 years, inclusive of equal proportion of male and female healthy participants.
- 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.
- 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.
- Participants with history of allergies.
- 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).
- Participants who have an underlying immunosuppressive condition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. Day 0 and end of week 4 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. Day 0 and end of week 4 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. Day 0 and end of week 4 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 Measures
Name Time Method To monitor for any adverse events during the study period
Trial Locations
- Locations (1)
DK Elite Health Care Centre
🇮🇳Pondicherry, PONDICHERRY, India
DK Elite Health Care Centre🇮🇳Pondicherry, PONDICHERRY, IndiaDr Sakthi BalanPrincipal investigator09443627722saheerose@gmail.com