Pressure InjuryAPG-PINCT07537101
Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients
A study testing combined Aloe Vera-Peppermint gel in people with Pressure Injury, run by Ali Abd-Alredha Hussein at 1 site in Iraq.
Trial summary
The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients. Does applying this natural gel reduce the incidence of pressure injuries compared to standard care? participants will be randomly assigned to either receive the gel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury
- What is being tested?
- combined Aloe Vera-Peppermint gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 5 Jun 2026to 20 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients aged 18 years or older.
- Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization.
- Unconsciousness, being under sedation or assisted ventilation.
- Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13-14.
- No Diarrhea, serum Albumin level below 3.5 g/dl, no edema.
- No limit of changes in body position with multiple injuries.
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- Family consent to participate in the study.
- The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease.
- All patients receiving standardized care (repositioning and pressure-relieving mattress).
Who cannot join
- Family's unwillingness for the patient to continue participation
- Sensitivity to Aloe Vera-Peppermint Gel after use on a patient's forearm (area of 2 × 2 cm) and this area was evaluated for the presence of redness, swelling and warmth within 45 min.
- Spinal cord injury cases
- death or patient transmission in less than 48 hrs. after admission to the ICU.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Baqubah Teaching Hospital
Baqubah, Diyala Governorate
Jameel yousif, master
About this study
Official title: Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients: A Randomized Controlled Trial
The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients.
Does applying this natural gel reduce the incidence of pressure injuries compared to standard care?
participants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.
- Conditions
- Pressure Injury
- Being tested
- combined Aloe Vera-Peppermint gel
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined Aloe Vera-Peppermint gelCombination product
Topical gel containing a combination of natural Aloe vera extract and peppermint oil. The intervention involves applying a thin layer of the gel to pressure-prone areas such as the sacrum and heels to prevent the development of pressure injuries. The application is performed twice daily during the patient's stay in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients in this group will receive a topical application of the combined Aloe Vera-Peppermint gel on pressure-prone areas. The gel will be applied twice daily, in addition to the standard nursing care protocol for pressure injury prevention. Receives: Combination Product: combined Aloe Vera-Peppermint gel |
| control group | No intervention | Patients in this group will receive the standard nursing care protocol for pressure injury prevention as practiced in the ICU, which includes regular repositioning, skin assessment, cleansing, moisturizing, and use of pressure-relieving devices. No experimental Aloe Vera-Peppermint gel will be applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pressure injuries
The number of participants who develop any new pressure injury during their ICU stay. Pressure injuries include Stage I, Stage II, Stage III, Stage IV, Unstageable, and Deep Tissue Pressure Injury, as defined by the National Pressure Injury Advisory Panel (NPIAP). Assessment will be performed daily by trained nursing staff using the Braden Scale and comprehensive clinical skin examination of pressure-prone areas.
Measured: From the date of ICU admission until 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start5 Jun 2026 (estimated)
- Primary completion28 Dec 2026 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Abd-Alredha Hussein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Abd-Alredha Hussein, University of Baghdad
- Investigators
- Mohammed Baqer Al-Jubouri, PhD, Study director, University of Baghdad / College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537101
- Sponsor's protocol ID
- 94
- Acronym
- APG-PI
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Aloe Vera-Peppermint Gel on Prevention Pressure Injuries Among Intensive Care Unit Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07537101
- Acronym / sponsor ID
- APG-PI / 94
- Conditions
- Pressure Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ali Abd-Alredha HusseinUniversity, hospital or other
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
The goal of this clinical trails is to learn if a combined Aloe Vera-Peppermint gel work to prevent pressure injuries (bedsores) in ICU patients.
Does applying this natural gel reduce the incidence of pressure injuries compared to standard care?
participants will be randomly assigned to either receive the gel application (Aloe Vera-Peppermint gel) or the standard hospital nursing care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Combination Product: combined Aloe Vera-Peppermint gelPatients in this group will receive a topical application of the combined Aloe Vera-Peppermint gel on pressure-prone areas. The gel will be applied twice daily, in addition to the standard nursing care protocol for pressure injury prevention. |
| control group | No intervention | –Patients in this group will receive the standard nursing care protocol for pressure injury prevention as practiced in the ICU, which includes regular repositioning, skin assessment, cleansing, moisturizing, and use of pressure-relieving devices. No experimental Aloe Vera-Peppermint gel will be applied to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ICU patients aged 18 years or older.
- Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization.
- Unconsciousness, being under sedation or assisted ventilation.
- Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13-14.
- No Diarrhea, serum Albumin level below 3.5 g/dl, no edema.
Key exclusion criteria (4 listed)
- Family's unwillingness for the patient to continue participation
- Sensitivity to Aloe Vera-Peppermint Gel after use on a patient's forearm (area of 2 × 2 cm) and this area was evaluated for the presence of redness, swelling and warmth within 45 min.
- Spinal cord injury cases
- death or patient transmission in less than 48 hrs. after admission to the ICU.
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 |
|---|---|---|
| combined Aloe Vera-Peppermint gelTopical gel containing a combination of natural Aloe vera extract and peppermint oil. The intervention involves applying a thin layer of the gel to pressure-prone areas such as the sacrum and heels to prevent the development of pressure injuries. The application is performed twice daily during the patient's stay in the ICU. | Combination product | experimental group |
Primary outcome
incidence of pressure injuries
Time frame: From the date of ICU admission until 10 days
The number of participants who develop any new pressure injury during their ICU stay. Pressure injuries include Stage I, Stage II, Stage III, Stage IV, Unstageable, and Deep Tissue Pressure Injury, as defined by the National Pressure Injury Advisory Panel (NPIAP). Assessment will be performed daily by trained nursing staff using the Braden Scale and comprehensive clinical skin examination of pressure-prone areas.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- 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.
Mohammed Baqer Al-Jubouri, PhD study director
University of Baghdad / College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined Aloe Vera-Peppermint gel in people with Pressure Injury, run by Ali Abd-Alredha Hussein at 1 site in Iraq.
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 9 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Apr 2026. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Abd-Alredha, master (+9647700752984, Ali.hussein2102m@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of pressure injuries (time frame: From the date of ICU admission until 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.