| CTRI Number |
CTRI/2025/03/082647 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of Antimicrobial Efficacy of Panchavalkal Kwatha and Povidone Iodine for Surgical Site Preparation on Human Skin Flora |
|
Scientific Title of Study
|
comparative study of antimicrobial efficacy of panchavalkal kwatha and povidone iodine for surgical site preparation on the human skin flora |
| 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 Kumari Sarita |
| Designation |
PG Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of
Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8887134139 |
| Fax |
|
| Email |
sy848996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Roy |
| Designation |
Associate Professor |
| Affiliation |
Department of PrInstitute of Medical Sciences Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of
Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranuradha369@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Roy |
| Designation |
Associate Professor |
| Affiliation |
Department of PrInstitute of Medical Sciences Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of
Medical Sciences Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranuradha369@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sundarlal Hospital Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu
University varanasi 221005 uttarpradesh India
|
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda Institute of Medical Sciences BHU |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda IMS BHU
Varanasi Uttarpradesh 221005 India |
| Type of Sponsor |
Government funding agency |
|
|
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 kumari sarita |
Sir Sunderlal Hospital BHU |
OPD No 24 Prasuti
Tantra OPD
Department of Prasuti
Tantra Faculty of
Ayurveda IMS BHU
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
08887134139
sy848996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of medical Science Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre operative patient |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | prakShAlana-karma, प्रक्षालन-कर्म | (Procedure Reference: Su.chikitsa sthana 1, Procedure details: Nyoghra Udumbar Aswatha Plaksha Parisha i.e panchavalkal kashaya will be applied locally on surgical site 10 min prior to operation in preoperative preparation after that 3 swabs will be taken immediately 2.5 min & after 30min of application. Then swab sample will be send for MIC microorganism growth & microbial load. In post-op during first follow up dressing will be done only with Panchavalkal kwatha & swab sample will be sent for microbial load)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Povidine iodine | Povidone-iodine is an antiseptic used for treating and preventing infections. It’s commonly used for cleaning wounds, prepping skin for surgery, or as a disinfectant for minor cuts and scrapes. It contains iodine, which has antimicrobial properties, helping to kill a wide range of bacteria, viruses, and fungi .It’s often found in the form of a solution or ointment. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients prepared for elective abdominal surgeries in Department of Prasuti Tantra SSH BHU and Department of Shalya Tantra SSH BHU |
|
| ExclusionCriteria |
| Details |
Patients having skin infection on lower abdominal area
Patients having a active untreated STDs
Patients having any severe systemic diseases where healing may be compromised Patients having severe anemia
Povidone iodine sensitive patients
Patient with irregular follow ups |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Based on Subjective and Objective criteria and
Laboratory investigations
Skin tolerability
Erythema
pruritis
scaliness
pain
oedema
Minimum Inhibition Concentration
Microorganisms growth/Microbial load
Surgical Outcomes |
2 Followup 2 week
FU1 on 3rd day
FU 2 on stitch removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased microbial load |
2followup 2 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
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
|
The skin flora of patients is one of the most important factors in pathogenesis of surgical site infection. There are two type of skin flora- Resident flora-Represents the organisms that always present on the whole skin surface including those in the deeper parts of the skin such as the ducts of sebaceous and sweat gland follicles. Flora consist predominantly Staph. epidermis, micrococci,diphtheroids Transient flora- Wider rang of organisms come in contact with the superficial aspect of skin from the environment, another person or from the persons own alimentary tract. Eg.Staphylococcus.aureus , E.coli ,Klebsiella Microorganisms are found all over the skin surface but species vary with anatomical sites- Dry Body sites mainly includes forearm,hands,leg and feet. Eg- coagulase negative staphy.epidermis and staphy.horminis. Moist sites includes skin folds, beneath breast,elbow crease,in between the groin. These are mainly cornybacterium Sebaceous sites includes head, neck, trunk area where oily substance sebum allows cutibacterium to thrive, some deodex mites and fungus Malasezzia also congregate in the oily. area of faces Microbes that exist on the skin are primarily gram positive. Staphylococcus epidermis is found in 85%- 100% of normal skin. Staphylococcus aureus is carried by 5%-25% of normal individuals. Propionibacterium is normal flora in 45%-100% |