Date

2020-01-18

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

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.

Next Version

According to the results of the in-vitro antimicrobial efficacy test conducted by using agar well diffusion method and stability tests, only the most active and stable three alcohol-based herbal hand scrub formulations (F1- Arm 1, F3 – Arm 3 & F5 – Arm 5) out of five and most active and stable two non-alcohol-based herbal hand scrub formulations (F1 – Arm 6 & F3 – Arm 8) out of six were selected for clinical trials to evaluate before application, 10 seconds and 15 seconds after application on the fingertip of the healthy human volunteer. The same procedure given in the original document has been conducted for 1st day of preparation, after 15th and 30th days.