| CTRI Number |
CTRI/2024/12/078558 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Other (Specify) [Invitro study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Invitro Investigation of the Antimicrobial Properties of parts of Nimba In Arka Form as a Hand Sanitizer. |
|
Scientific Title of Study
|
Invitro Study of Anti-Microbial Activity of Nimba Patra, Pushpa, Beeja, Twak Arka as a Hand Sanitizer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula Kivadasannavar |
| Designation |
Professor HoD |
| Affiliation |
Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Department of Roga Nidana
Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590005
India |
| Phone |
9844946360 |
| Fax |
|
| Email |
manjula.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula A Vagarali |
| Designation |
Professor |
| Affiliation |
J N Medical College |
| Address |
Department of Microbiology
J N Medical College
Nehru Nagar
Belagavi
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9980932347 |
| Fax |
|
| Email |
drmanjulavagrali@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula A Vagarali |
| Designation |
Professor |
| Affiliation |
J N Medical College |
| Address |
Department of Microbiology
J N Medical College
Nehru Nagar
Belagavi
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9980932347 |
| Fax |
|
| Email |
drmanjulavagrali@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research
Deemed to be University
JNMC Campus
Nehru Nagar
Belagavi 590 010
Karnataka |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KLE Academy of Higher Education and Research
Deemed to be University
JNMC Campus
Nehru Nagar
Belagavi
Karnataka |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjula A Vagarali |
KLE Academy of Higher Education and Research |
KLE Academy of Higher Education and Research
Deemed to be University
JNMC Campus
Nehru Nagar
Belagavi 590 010
Karnataka
Belgaum
KARNATAKA |
9980932347
drmanjulavagrali@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants should not have used topical or systemic antimicrobial agents or any other medication known to affect the microbial flora of the skin before 5 hours from the time of swab collection |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangadara, Procedure details: Application the Nimba Arka on the palm leave the solution for 5min and rub gently both palms)
(1) Medicine Name: Nimba Arka, Reference: Sharangadhara, Route: Topical, Dosage Form: Arka, Dose: 10(ml), Frequency: sos, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Medical professionals willing to sign the informed consent form
Participants should not have used topical or systemic antimicrobial agents or any other medication known to affect the microbial flora of the skin before 5 hours from the time of swab collection
|
|
| ExclusionCriteria |
| Details |
Volunteers of cuts Volunteers with cuts abrasions skin manifestations
Participants having nails greater than 2 mm having artificial nails or wearing non-removable jewelry
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is Antimicrobial Activity in The Nimba Patra Pushpa Beeja Twak Arka as a Sanitizer |
The subjects are recruited sample is collected and processed for further steps on the baseline Day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
NIl |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Sushruta
contributed and considered Hasta to be the main shastra. Hasta is the most
essential requirement to carry any basic (simple) karma to the most complicated
robotic surgery. On the contrary, hands are the main source of infection &
disease transmission. In the medical profession, hand asepsis is recognized as an
important measure for the prevention of disease transmission, through antiseptics,
surgical scrubs, alcohol-based hand rubs, etc. The alcohol ethanol-based hand
sanitizer has side effects like dryness, itching, hyperkeratinisation, skin
peelings, and contact dermatitis in hypersensitive humans. The vulnerable group
of hyper-sensitive humans does require a non-alcohol and chemical-free hand
sanitizer. After screening the Ayurvedic classics Nimba emerges to be having krimihara & vishaghna
properties. In the present study, an attempt will be made to evaluate the anti-microbial
effect before and after treatment with Nimba patra arka, Nimba pushpa arka, Nimba beeja arka,
Nimba twak arka as a hand sanitizer. |