【ChiCTR2600131501】Effect of Aloe Vera- Peppermint compound gel in prevention bed injuries among ICU bedridden patients

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基本信息

登记号

ChiCTR2600131501

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-09-03

临床申请受理号

靶点

适应症

Pressure injuries

试验通俗题目

Effect of Aloe Vera- Peppermint compound gel in prevention bed injuries among ICU bedridden patients

试验专业题目

Effectiveness of a Combined Aloe Vera–Peppermint Gel on Prevention Pressure Injuries among Intensive Care Unit Patients: A Randomized Controlled Trial

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

Bab Al-Muaadham-Baghdad-Iraq

联系人通讯地址

临床试验信息

试验目的

1. To evaluate the effectiveness of an Aloe Vera–Peppermint compound gel in the prevention of pressure injuries among ICU patients. 2. To examine the relationship between the use of Aloe Vera–Peppermint gel and the demographic characteristics of ICU patients in relation to pressure injury prevention.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Patients were assigned to the two groups using simple random sampling method

盲法

Open-label

试验项目经费来源

Self-funded

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-04-10

试验终止时间

2027-04-15

是否属于一致性

入选标准

1.ICU patients aged 18 years or older. 2.Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization. 3.Unconsciousness, being under sedation or assisted ventilation. 4.Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13–14. 5.No Diarrhea, serum Albumin level below 3.5 g/dl, no edema. 6.No limit of changes in body position with multiple injuries. 7.Family consent to participate in the study. 8.The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease. 9.All patients receiving standardized care (repositioning and pressure-relieving mattress). 1.ICU patients aged 18 years or older.2.Admission to the ICU without pressure injury according to the NPUAP scale on the first day of hospitalization.3.Unconsciousness, being under sedation or assisted ventilation.4.Patients that are at risk of moderate to severe PIs according to Braden scoring tool and scored less than 13–14.5.No Diarrhea, serum Albumin level below 3.5 g/dl, no edema.6.No limit of changes in body position with multiple injuries.7.Family consent to participate in the study.8.The patient has no history of autoimmune diseases, renal failure, or diabetes, does not use immunosuppressive medications, and has no evidence of vascular disease.9.All patients receiving standardized care (repositioning and pressure-relieving mattress).；

排除标准

1.Family’s unwillingness for the patient to continue participation 2.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. 3.Spinal cord injury cases 4.Death or patient transmission in less than 48 hrs. after admission to the ICU.；

研究者信息

研究负责人姓名

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试验机构

University of Baghdad, College of Nursing

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

Bab Al-Muaadham-Baghdad-Iraq

联系人通讯地址