| CTRI Number |
CTRI/2025/12/099937 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of turmeric mouthwash and chlorhexidine mouthwash on prevention of lung infection in patients on ventilators |
|
Scientific Title of Study
|
Evaluation of the effect of curcumin and chlorhexidine mouthwash on oral biofilm colonization and progression of ventilator associated pneumonia in mechanically ventilated patient: A randomized clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhi Katiyar |
| Designation |
Junior resident |
| Affiliation |
Faculty of Dental Sciences, King Georges Medical University |
| Address |
Room No. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8920180256 |
| Fax |
|
| Email |
shubhikatiyar2110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavitra Rastogi |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, King Georges Medical University |
| Address |
Room No. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8787221239 |
| Fax |
|
| Email |
pavitrarastogi@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavitra Rastogi |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, King Georges Medical University |
| Address |
Room No. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8787221239 |
| Fax |
|
| Email |
pavitrarastogi@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Shubhi Katiyar |
Faculty of Dental Sciences, King Georges Medical University |
Room No. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH |
08920180256
shubhikatiyar2110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University U.P., Institutional Ethics Committee Lucknow-226003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J22||Unspecified acute lower respiratory infection. Ayurveda Condition: NIDRA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | curcumin mouthwash | (Procedure Reference: NIL, Procedure details: The first application will be done within twenty four hours of admission.
Before applying the mouthwash the head of the bed will be elevated by thirty degrees to reduce aspiration. Oral & tracheal secretions will be suctioned. Using sterile gloves & cotton swabs fifteen milliliter of the assigned mouthwash will be applied to the oral mucosa teeth tongue & gingiva. Excess secretions will be suctioned & the lips will be lubricated. This procedure will be repeated twice daily.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | CHLORHEXIDINE MOUTHWASH | . The first application will be done within twenty four hours of admission.
Before applying the mouthwash the head of the bed will be elevated by thirty degrees to reduce aspiration. Oral and tracheal secretions will be suctioned. Using sterile gloves and cotton swabs fifteen milliliter of the assigned mouthwash will be applied to the oral mucosa teeth tongue and gingiva. Excess secretions will be suctioned and the lips will be lubricated. This procedure will be repeated twice daily. |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
No history of pneumonia at the time of admission or prior history of pulmonary disease
No allergy to curcumin
No covid 19 infection
Patient willing to participate
|
|
| ExclusionCriteria |
| Details |
Facial fractures
Pneumonia at the time of admission
Patients not willing to give consent
Fever greater than 38.50
Covid 19 infection
APACHE 2 score greater than 30
More than three attempts at intubation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ONSET AND PROGRESSION OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS |
the outcome will be assesed on day 0, day 3, day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes
Plaque Index
Measured at baseline, Day 4, and Day 8
Beck Oral Assessment Scale scores
Measured at baseline, Day 4, and Day 8
Change in periodontal parameters
Clinical attachment level and probing pocket depth
Effect of periodontal status on progression of VAP |
the outcome will be assesed on day 0, day 4, day 8 |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/01/2026 |
| 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="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
|
Ventilator-associated pneumonia is a common hospital-acquired infection occurring in mechanically ventilated ICU patients, mainly due to aspiration of oropharyngeal secretions and increased bacterial colonization. Oral hygiene plays a crucial role in reducing the microbial load and preventing the development of VAP. Chlorhexidine is widely used as a chemical plaque control agent due to its broad-spectrum antimicrobial activity, whereas curcumin, a natural compound derived from Curcuma longa, possesses anti-inflammatory, antioxidant, and antimicrobial properties and has shown potential as an effective oral care agent. This randomized clinical trial aims to compare the effect of curcumin mouthwash and chlorhexidine mouthwash on the incidence and progression of ventilator-associated pneumonia in mechanically ventilated ICU patients. A total of 142 participants will be randomly allocated into two groups: Group 1 will receive chlorhexidine mouthwash as part of oral care, and Group 2 will receive curcumin mouthwash. Oral assessments, plaque index, Beck Oral Assessment Scale, and modified Clinical Pulmonary Infection Score will be recorded at baseline, day 4, and day 8. The study will also evaluate the influence of periodontal status on VAP progression. Findings may provide evidence for integrating herbal alternatives like curcumin into ICU oral care protocols. Primary Outcome
Incidence of ventilator associated pneumonia measured using Modified Clinical Pulmonary Infection Score at baseline day 4 and day 8. Secondary Outcomes
Plaque Index Silness and Loe 1964 measured at baseline day 4 and day 8.
Beck Oral Assessment Scale scores measured at baseline day 4 and day 8.
Change in periodontal parameters including clinical attachment level and probing pocket depth.
Effect of periodontal status on progression of ventilator associated pneumonia.
Group 1 Chlorhexidine Mouthwash
Intervention 15 ml of chlorhexidine mouthwash applied using sterile cotton swabs.
Frequency twice daily.
Duration from admission within 24 hours until day 8 or extubation.
Procedure oral cavity gingiva and tongue will be cleaned secretions will be suctioned lips will be lubricated. Group 2 Curcumin Mouthwash
Intervention 15 ml of curcumin mouthwash applied using sterile cotton swabs.
Frequency twice daily.
Duration from admission within 24 hours until day 8 or extubation.
Procedure same oral care protocol as group 1. |