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临床试验/CTRI/2025/12/099937
CTRI/2025/12/099937尚未招募Unknown

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

未提供1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
142
试验地点
1
主要终点
ONSET AND PROGRESSION OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
19.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

ONSET AND PROGRESSION OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS

时间窗: the outcome will be assesed on day 0, day 3, day 8

次要结局

  • Secondary Outcomes(Plaque Index)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Shubhi Katiyar

Faculty of Dental Sciences, King Georges Medical University

研究点 (1)

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