| CTRI Number |
CTRI/2025/07/090736 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
CITRIC ACID EFFECTS ON WOUND |
|
Scientific Title of Study
|
A 1 YEAR RANDOMIZED CONTROLLED TRIAL TO COMPARE EFFECTS OF CITRIC ACID DRESSINGS VS CONVENTIONAL DRESSINGS(10% BETADINE DRESSINGS) ON WOUND HEALING IN PATIENTS WITH ULCERS AT A TERTIARY CARE HOSPITAL |
| 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. Dev Bhojwani |
| Designation |
Junior Resident |
| Affiliation |
KLE UNIVERSITY |
| Address |
KLE UniversityJawaharlal Nehru Medical College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7208337519 |
| Fax |
|
| Email |
devb171717@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ramesh Koujalagi |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery
KLE Jawaharlal Nehru Medical College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8970738515 |
| Fax |
|
| Email |
drrameshkoujalagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ramesh Koujalagi |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery
KLE Jawaharlal Nehru Medical College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8970738515 |
| Fax |
|
| Email |
drrameshkoujalagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE University Jawaharlal Nehru Medical College Belgaum INDIA 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Dev Bhojwani |
| Address |
KLE University Jawaharlal Nehru Medical College Belgaum INDIA 590010 |
| Type of Sponsor |
Other [self] |
|
|
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 Dev Bhojwani |
KLEs Dr. Prabhakar Kore Hospital And Medical Research Centre |
Department Of General Surgery
KLE Jawaharlal Nehru Medical College Belgaum KARNATAKA
Belgaum
KARNATAKA |
7208337519
devb171717@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
10 % betadine |
10 % povidine iodine dressings for 14 days |
| Intervention |
CITRIC ACID |
3 PERCENT CITRIC ACID DILUTED WITH NORMAL SALINE FOR 14 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
WILLING TO PARTICIPATE IN STUDY
GRADE 1 & 2 ULCERS |
|
| ExclusionCriteria |
| Details |
Age above 70 years and age less than 18 years
Patients with serious co-morbidities like coagulopathies or ASA-3 and above
Patients on psychotropic drugs or history of drug abuse
Patients with grossly distorted liver or renal function parameters
Patients on corticosteroids, chemotherapy, immunosuppressants, or anticoagulation therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO KNOW THE EFFICACY OF CITRIC ACID IN ULCER HEALING |
Every alternate day till two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO KNOW THE EFFICACY OF CITRIC ACID AS ANTIMICROBIAL AGENT |
DAY 2,4,8,11,13 |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
24/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Citric acid has a lengthy history of usage initially in dental and later in surgical applications. It’s primary use resolver around altering wouynd pH , thereby hindering bacterial growth, enhancing oxygen levels , and fostering the movement and growth of fibroblasts. considering it’s cost , clinical management and possible effect on ulcers . |