Home » Trials » SLCTR/2019/016
Formulation and evaluation of the antimicrobial efficacy of novel alcohol based and non-alcohol based natural hand scrubs with medicinal plant extracts
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SLCTR Registration Number
SLCTR/2019/016
Date of Registration
The date of last modification
Sep 16, 2020
Trial Status
Scientific Title of Trial
Formulation and evaluation of the antimicrobial efficacy of novel alcohol based and non-alcohol based natural hand scrubs with medicinal plant extracts
Public Title of Trial
Formulation and evaluation of the antimicrobial efficacy of a novel alcohol based and a novel non-alcohol based hand scrub with medicinal plant extracts against a commercial preparation – A Randomized Controlled Trial
Disease or Health Condition(s) Studied
Hand Hygiene
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1226-9390
Any other number(s) assigned to the trial and issuing authority
32/2015: ERC Medical Research Institute, Colombo 08
What is the research question being addressed?
Do alcohol based and non-alcohol based hand scrubs with medicinal plant extracts have adequate antimicrobial efficacy as hand hygiene agents compared to a predefined synthetic hand hygiene agent available in the market?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Active
Assignment
Other
Purpose
Health services research
Study Phase
Phase 2
Intervention(s) planned
Study setting – Department of Bacteriology in Medical Research Institute, Colombo 08.
Negative control - Water
Positive control – Selected commercially available product
Alcohol based hand scrubs
• Formula 01 – Ethanol + Aloe juice + Clove oil + Glycerin Arm 1- Formula 1 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 02 – Ethanol + Aloe juice + Cinnamon oil + Glycerin Arm 2 - Formula 2 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 03 – Ethanol + Aloe juice + Clove oil Arm 3 - Formula 3 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 04 – Ethanol + Aloe juice + Cinnamon oil Arm 4 - Formula 4 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 05 – 4% Chlorhexidiene + Aloe juice Arm 5 - Formula 5 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
Non -alcohol based hand scrubs
• Formula 01 – Aloe juice + Clove oil + Glycerin Arm 6 - Formula 1 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 02 – Aloe juice + Cinnamon oil + Glycerin Arm 7 - Formula 2 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 03 – Aloe juice + Clove oil Arm 8 - Formula 3 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 04 – Aloe juice + Cinnamon oil Arm 9 - Formula 4 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 05 – Aloe juice + Nutmeg oil Arm 10 - Formula 5 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
• Formula 06 – Aloe juice + Castor oil Arm 11 - Formula 6 on right thumb (N=30) Negative control on left thumb (N=15) and positive control on left thumb (N=15 each)
Procedure/Intervention
For one formulation,
Step1: A group of healthy human volunteers will be recruited and will be assigned to each arm randomly using an [include random assignment method].
Step 2: Each participant will be asked to place both their thumbs on two separate blood agar plates (one for each thumb) before application of any formulations.
Step 3: Then the assigned formula will be applied on one thumb and at the same time a control (negative or positive control as assigned) will be applied on the other thumb of each participant with the support of two persons (Researcher + Supporter).
Step 4: Step 3 will be repeated where participants will be asked to place both thumbs on two fresh blood agar plates (which are divided into three parts) after 10 s and 15 s of application of the particular formulation and control.
Step 5: Overnight incubation of agar plates at [give conditions]
Step 6: Following overnight incubation, the colony count on the incubated blood agar plates will be counted by the same researcher using a bacterial colony counter. Formulations or controls will be applied using a sterile cotton wool on whole thumb including nails up to palm and fingertip will be kept on agar plates according to the standard published procedure.
Inclusion criteria
• Healthy human volunteers • Both men and women • Age 18 years and above
Exclusion criteria
• Participants who have allergies, eczema and other skin conditions (wounds)
Primary outcome(s)
1.
Antimicrobial efficacy measured by counting the number of microbial colonies using a colony counter |
[ 24 hours after applying the formula/control ] |
Secondary outcome(s)
1.
Participants’ skin compatibility measured by a self-administered questionnaire |
[ 10-15 minutes following application of the formula/control. ] |
Target number/sample size
330 (30 per each formula)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-04-22
Anticipated end date
2019-09-22
Date of first enrollment
2019-06-02
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Medical Research Institute
Regulatory approvals
Status
Approved
Date of Approval
2019-01-31
Approval number
32/2015
Details of Ethics Review Committee
Name: | Ethics Review Committee, Medical Research Institute, Ministry of Health |
Institutional Address: | P.O. Box 527, Dr Danister De Silva Mawatha (Baseline Road), Colombo 00800 Sri Lanka |
Telephone: | +94-11-2693532 (Extension: 353) |
Email: | erc_mri2016@hotmail.com |
Contact person for Scientific Queries/Principal Investigator
Shanika Karunanayaka
Lecturer (Probationary)
Department of Pharmacy,
Faculty of Allied Health Sciences,
University of Ruhuna,
Sri Lanka.
0912232896
0718258048
svkshani@gmail.com, vindyakarunanayaka@ahs.ruh.ac.lk
Contact Person for Public Queries
Dr. Sujeewa Krishanthi Hettihewa
Senior Lecturer (Grade II)
Department of Pharmacy,
Faculty of Allied Health Sciences,
University of Ruhuna,
Sri Lanka.
0912232896
0711943078
krishanthi2001@.yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Not applicable
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Yes
Date of posting results
Date of study completion
Final sample size
450 (For each formulation 1st day, 15th and 30th day)
Date of first publication
Link to results
Brief summary of results
All novel hand scrubs tested are having promising antimicrobial efficacy along with standard skin compatibility.