| CTRI Number |
CTRI/2025/11/096966 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Vitamin C in preventing urinary infections related to catheter in admitted patients undergoing general surgery |
|
Scientific Title of Study
|
Efficacy and Safety of Ascorbic Acid in Prevention of Catheter Associated Urinary Tract Infections in Institutionalized Patients Undergoing Elective General Surgery - A Double Blinded Randomized Controlled Study |
| 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 Navya Thakur |
| Designation |
Postgraduate resident |
| Affiliation |
University college of medical sciences and Guru Teg Bahadur Hospital |
| Address |
Ward 12 and 24, Unit 6, Department of general surgery, UCMS GTBH, Taharpur road, Dilshad garden, Delhi
East
DELHI
110095
India |
| Phone |
9993429861 |
| Fax |
|
| Email |
thakurnavya.2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Thakur |
| Designation |
Postgraduate resident |
| Affiliation |
University college of medical sciences and Guru Teg Bahadur Hospital |
| Address |
Ward 12 and 24, Unit 6, Department of General Surgery, UCMS GTBH, Taharpur road, Dilshad garden, Delhi
East
DELHI
110095
India |
| Phone |
9993429861 |
| Fax |
|
| Email |
thakurnavya.2018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya Thakur |
| Designation |
Postgraduate resident |
| Affiliation |
University college of medical sciences and Guru Teg Bahadur Hospital |
| Address |
Ward 12 and 24, Unit 6, Department of general surgery, UCMS GTBH, Taharpur road, Dilshad garden, Delhi
East
DELHI
110095
India |
| Phone |
9993429861 |
| Fax |
|
| Email |
thakurnavya.2018@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Iqbal Singh |
Guru Teg Bahadur Hospital |
Ward 12 and 24, Unit 6, Department of general surgery, Guru Teg Bahadur Hospital Taharpur road Dilshad garden Delhi
North East
DELHI |
9810499222
iqbalsinghp@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (3) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, (4) ICD-10 Condition: K65-K68||Diseases of peritoneum and retroperitoneum, (5) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (6) ICD-10 Condition: K40-K46||Hernia, (7) ICD-10 Condition: A00-A09||Intestinal infectious diseases, (8) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (9) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (10) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (11) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (12) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (13) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ascorbic acid |
500 mg TDS for 10 days |
| Comparator Agent |
Placebo |
Streptococcus faecalis 30.0 M, Clostridium butyricum 2.0 M, Bacillus
mesentericus 1.0 M, Lactic acid bacillus 50.0 M for a period of 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective general surgery
Patients with negative pre-catheterization urine culture |
|
| ExclusionCriteria |
| Details |
Patients with mental disorders or illness who cannot understand or comply with
the study protocol
Patients with known drug allergy/contraindications to ascorbic acid
Patients on antimicrobials
Any patients with difficult catheterization |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of catheter associated urinary tract infections in patients undergoing elective
general surgery |
Catheterization to 10 days post catheter removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment emergent adverse effects (TEAE) |
Catheterization to 10 days post catheter removal |
| Incidence of urosepsis as defined by SIRS criteria |
Catheterization to 10 days post catheter removal |
Complications of CAUTI and per urethral catheterization as per modified
Clavien-Classification system |
Catheterization to 10 days post catheter removal |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
17/11/2025 |
| 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="3"
Days="7" |
|
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
|
The study is a double blinded randomized controlled study where group A and B would be treated with ascorbic acid and placebo respectively. The urine samples would be collected on multiple occasions including the preoperative screening. The samples would thereafter be taken on the day of catheterization, 48 hrs post-catheterization, foley tip culture on day of removal, 48 hours post removal of catheter and 1 week post removal of catheter. Any single positive urine culture would be classified as CAUTI and thereafter at the end of study, data would be analysed to compare CAUTI between the two groups as the primary outcome. |