Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle

Renal Failure Clinical Trial

Official title:

Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02865980
• Other study ID #: 95150200
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2016
• Last updated: August 10, 2016
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Mashhad University of Medical Sciences
• Contact: Ali Bazzi, MSc
• Phone: 989113723582
• Email: bazzia911[@]gmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial will conducted involving 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block). In the both intervention and control group, first will be washed the Catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.

Description:

This study is a randomized clinical trial that will conducted on 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block).

In the both intervention and control group, first will be washed the shaldon catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 18-80

Exclusion Criteria:

• lack of cooperation patient to participate in the post test

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Inflammation
• Renal Failure
• Renal Insufficiency

Intervention

Other:
• clove extract
in intervention group, first will be washed the Catheter with Betadine after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence of inflammation of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.
• Betadine
in control group, will be washed the Catheter with Betadine

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad Faculty of Nursing and Midwifery	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Chaudhari LK, Jawale BA, Sharma S, Sharma H, Kumar CD, Kulkarni PA. Antimicrobial activity of commercially available essential oils against Streptococcus mutans. J Contemp Dent Pract. 2012 Jan 1;13(1):71-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation severity questionnaire	effects of washing with clove extract on inflammation place logging shaldon needles in the hemodialysis patients that will be measured with inflammation severity questionnaire.	6 weeks	Yes

External Links

•   abstract article