Renal FailureNCT02865980
Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
A study testing clove extract and Betadine in people with Renal Failure, run by Mashhad University of Medical Sciences at 1 site in Iran.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Failure
- What is being tested?
- clove extract and Betadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Aug 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18-80
Who cannot join
- lack of cooperation patient to participate in the post test
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mashhad Faculty of Nursing and Midwifery
Mashhad, Razavi Khorasan Province
Ali Bazzi, MSc, 989113723582, bazzim911@gmail.com
About this study
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.
Read the detailed 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.
- Conditions
- Renal Failure
- Being tested
- clove extract, Betadine
- Keywords
- inflammation, infection
- Medical subject headings
- Renal Insufficiency, Inflammation, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clove extractOther
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.
BetadineOther
in control group, will be washed the Catheter with Betadine
| Study group | Role | What they receive |
|---|---|---|
| inflammation | Experimental | The effect of washing with betadine and clove extract on incidence of inflammation place logging shaldon catheter in the hemodialysis patients Receives: Other: clove extract; Other: Betadine |
| infection | Experimental | The effect of washing with betadine and clove extract on incidence of infection place logging shaldon catheter in the hemodialysis patients Receives: Other: clove extract; Other: Betadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali bazzi, Mashhad University of Medical Sciences
- Investigators
- Ali Bazzi, MSc, Principal investigator, Mashhad Faculty Nursing and Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865980
- Sponsor's protocol ID
- 95150200
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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. doi: 10.5005/jp-journals-10024-1098.
PubMed 22430697
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle
- ClinicalTrials.gov ID
- NCT02865980
- Acronym / sponsor ID
- 95150200
- Conditions
- Renal Failure
- Keywords
- inflammation, infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inflammation | Experimental | Other: clove extract, Other: BetadineThe effect of washing with betadine and clove extract on incidence of inflammation place logging shaldon catheter in the hemodialysis patients |
| infection | Experimental | Other: clove extract, Other: BetadineThe effect of washing with betadine and clove extract on incidence of infection place logging shaldon catheter in the hemodialysis patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age between 18-80
Key exclusion criteria (1 listed)
- lack of cooperation patient to participate in the post test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clove extractin 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. | Other | infection, inflammation |
| Betadinein control group, will be washed the Catheter with Betadine | Other | infection, inflammation |
Primary outcome
inflammation severity questionnaire
Time frame: 6 weeks
effects of washing with clove extract on inflammation place logging shaldon needles in the hemodialysis patients that will be measured with inflammation severity questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Results publication: PubMed 22430697Chaudhari 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. doi: 10.5005/jp-journals-10024-1098.
- abstract articleLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Bazzi, MSc principal investigator
Mashhad Faculty Nursing and Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clove extract and Betadine in people with Renal Failure, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Bazzi, MSc (989113723582, bazzia911@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation severity questionnaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.