PhlebitisNCT06030141
Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis
A study testing sesame oil application and nigella sativa oil application in people with Phlebitis and Peripheral Venous Catheterization, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Phlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Phlebitis, Peripheral Venous Catheterization
- What is being tested?
- sesame oil application and nigella sativa oil application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 1 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and over,
- IV amiodarone treatment was started,
- PIC applied to the cephalic or basilic vein,
- Number 20 catheter is preferred in PIC application,
- At least primary school graduate and can speak Turkish,
- Patients who voluntarily agree to participate in the study will be included in the study.
Who cannot join
- Diagnosed with active phlebitis,
- Having a diagnosis of mental illness or communication problems,
- Hearing and vision problems,
- Skin integrity is impaired,
- Having a body temperature above 38.5 Cº,
- Stating that he is allergic to sesame oil and black cumin oil,
Show all 10Show fewer
- Receiving irritant medication or liquid other than Amiodarone through the catheter,
- Receiving long-term IV therapy from cephalic or basilic veins,
- Mastectomy surgery, fistula,
- who have been diagnosed with SVO,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Training and Research Hospital
Merkez, Kütahya, 43200
About this study
Phlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access.
Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.
Read more
However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%.
Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis.
Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4.
There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.
Read the detailed description
hlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access.
Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.
However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%.
Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis.
Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4.
There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.
- Conditions
- Phlebitis, Peripheral Venous Catheterization
- Being tested
- sesame oil application, nigella sativa oil application
- Keywords
- Phlebitis, nigella sativa oil, sesame oil, Peripheral Venous Catheterization
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sesame oil applicationOther
sesame oil application
nigella sativa oil applicationOther
nigella sativa oil application
| Study group | Role | What they receive |
|---|---|---|
| nigella sativa oil application group | Experimental | Peripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. Determine the distal peripheral venous catheter (3.2 cm length from the entry point for catheter 20) An area of 10 cm will be determined from the distal of the catheter. Nigella sativa oil is dripped 5 drops on a 10 cm area.
The dripped oil is applied without massaging, Nigella Sativa oil will be applied to the patients in the application group before the start of amiodarone infusion and at 6-hour intervals. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours. Receives: Other: nigella sativa oil application |
| Sesame oil application group | Experimental | Peripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. Determine the distal peripheral venous catheter (3.2 cm length from the entry point for catheter 20) An area of 10 cm will be determined from the distal of the catheter. Sesame oil is dripped 5 drops on a 10 cm area.
The dripped oil is applied without massaging, The dripped oil is applied without massaging, Sesame oil will be applied to the patients in the application group before the start of amiodarone infusion and at 6-hour intervals. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours. Receives: Other: sesame oil application |
| control group | No intervention | Peripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. No oil application will be made. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual infusion phlebitis scale
The scale has Turkish validity and durability.No change is expected in the Visual Infusion Phlebitis Scale score (2 points and above) in the sesame oil administration group (36 individual)
Measured: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
visual infusion phlebitis scale
The scale has Turkish validity and durability.No change is expected in the Visual Infusion Phlebitis Scale score (2 points and above) in the nigella sativa oil administration group (36 individual)
Measured: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
visual infusion phlebitis scale
The scale has Turkish validity and durability.Changes in the Visual Infusion Phlebitis Scale score (2 points and above) are expected in the control group (36 individuals).
Measured: Phlebitis formation is expected during the follow-up period (72 hours) in the control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Nov 2023
- Primary completion25 Aug 2024
- Study completion1 Oct 2024
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 PhlebitisStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Model description
- In this study, catheter application and follow-up will be carried out by the researcher Burcu Nal, and phlebitis evaluation will be made by a specialist nurse other than the researcher. Patients will be aware that they are included in the study, but they will be blinded as one of the oils applied in the care they will be given will be used by hiding the information of which group they are in. In order to prevent bias, patients will be included in the study groups according to the assignment made from the Randomizer.org program. Since the data will be transferred to the SPSS program and the analysis will be done by an independent statistician, the bias will also be controlled in the data evaluation process.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURCU NAL, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030141
- Sponsor's protocol ID
- KSBUHSU
- Status last verified
- Mar 2025
- First submitted
- 15 Aug 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nal B, Sari D, Astarcioglu MA, Sen I. Effect of sesame oil and Nigella sativa oil on the prevention of amiodarone-induced phlebitis: a randomized controlled trial. Explore (NY). 2026 May-Jun;22(3):103403. doi: 10.1016/j.explore.2026.103403. Epub 2026 Mar 18.
PubMed 41880716
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis
- ClinicalTrials.gov ID
- NCT06030141
- Acronym / sponsor ID
- KSBUHSU
- Conditions
- Phlebitis, Peripheral Venous Catheterization
- Keywords
- Phlebitis, nigella sativa oil, sesame oil, Peripheral Venous Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 Sep 2023 (actual)
- 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.
Phlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access.
Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.
However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%.
Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis.
Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4.
There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.
Detailed description
hlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access.
Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.
However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%.
Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis.
Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4.
There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- In this study, catheter application and follow-up will be carried out by the researcher Burcu Nal, and phlebitis evaluation will be made by a specialist nurse other than the researcher. Patients will be aware that they are included in the study, but they will be blinded as one of the oils applied in the care they will be given will be used by hiding the information of which group they are in. In order to prevent bias, patients will be included in the study groups according to the assignment made from the Randomizer.org program. Since the data will be transferred to the SPSS program and the analysis will be done by an independent statistician, the bias will also be controlled in the data evaluation process.
| Arm | Type | Receives |
|---|---|---|
| nigella sativa oil application group | Experimental | Other: nigella sativa oil applicationPeripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. Determine the distal peripheral venous catheter (3.2 cm length from the entry point for catheter 20) An area of 10 cm will be determined from the distal of the catheter. Nigella sativa oil is dripped 5 drops on a 10 cm area. The dripped oil is applied without massaging, Nigella Sativa oil will be applied to the patients in the application group before the start of amiodarone infusion and at 6-hour intervals. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours. |
| Sesame oil application group | Experimental | Other: sesame oil applicationPeripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. Determine the distal peripheral venous catheter (3.2 cm length from the entry point for catheter 20) An area of 10 cm will be determined from the distal of the catheter. Sesame oil is dripped 5 drops on a 10 cm area. The dripped oil is applied without massaging, The dripped oil is applied without massaging, Sesame oil will be applied to the patients in the application group before the start of amiodarone infusion and at 6-hour intervals. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours. |
| control group | No intervention | –Peripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. No oil application will be made. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and over,
- IV amiodarone treatment was started,
- PIC applied to the cephalic or basilic vein,
- Number 20 catheter is preferred in PIC application,
- At least primary school graduate and can speak Turkish,
Key exclusion criteria (10 listed)
- Diagnosed with active phlebitis,
- Having a diagnosis of mental illness or communication problems,
- Hearing and vision problems,
- Skin integrity is impaired,
- Having a body temperature above 38.5 Cº,
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 |
|---|---|---|
| sesame oil applicationsesame oil application | Other | Sesame oil application group |
| nigella sativa oil applicationnigella sativa oil application | Other | nigella sativa oil application group |
Primary outcome
visual infusion phlebitis scale
Time frame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
The scale has Turkish validity and durability.No change is expected in the Visual Infusion Phlebitis Scale score (2 points and above) in the sesame oil administration group (36 individual)
visual infusion phlebitis scale
Time frame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
The scale has Turkish validity and durability.No change is expected in the Visual Infusion Phlebitis Scale score (2 points and above) in the nigella sativa oil administration group (36 individual)
visual infusion phlebitis scale
Time frame: Phlebitis formation is expected during the follow-up period (72 hours) in the control group.
The scale has Turkish validity and durability.Changes in the Visual Infusion Phlebitis Scale score (2 points and above) are expected in the control group (36 individuals).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 41880716Nal B, Sari D, Astarcioglu MA, Sen I. Effect of sesame oil and Nigella sativa oil on the prevention of amiodarone-induced phlebitis: a randomized controlled trial. Explore (NY). 2026 May-Jun;22(3):103403. doi: 10.1016/j.explore.2026.103403. Epub 2026 Mar 18.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sesame oil application and nigella sativa oil application in people with Phlebitis and Peripheral Venous Catheterization, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual infusion phlebitis scale (time frame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.). The study lists 3 primary outcomes in all. 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 NCT06030141, 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 6 Mar 2025.