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

-

SLCTR Registration Number

SLCTR/2019/016


Date of Registration

22 Apr 2019

The date of last modification

May 13, 2019



Application Summary


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


Trial Details


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,

  1. Step1: A group of healthy human volunteers will be recruited and will be assigned to each arm randomly using an [include random assignment method].

  2. 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.

  3. 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).

  4. 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.

  5. Step 5: Overnight incubation of agar plates at [give conditions]

  6. 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


Date of study completion


Recruitment status

Pending


Funding source

Medical Research Institute


Regulatory approvals



State of Ethics Review Approval


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 & Sponsor Information


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

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


Primary study sponsor/organization

Medical Research Institute
Health Organization
Medical Research Institute, Colombo 08, Sri Lanka.
0112693532


Secondary study sponsor (If any)

None





Trial Completion details


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

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results