Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 主要终点
- Number Of Days Prior To Elevation of Platelet Count Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.
研究概览
简要总结
Dengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action.
This is a randomized control trial to determine the effectiveness of adjunctive melatonin therapy among patients diagnosed with Dengue fever with Warning Signs. This would include children aged 5 to 18 years old with no signs of hemmorhagic shock. They would be randomly assigned into 2 groups. Baseline Complete blood count with platelet (CBCPC) will be collected. Daily CBCPC will be collected and would be statistically analyze after the study.
详细描述
Dengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action.
Main Objective:
To determine the effectiveness of Melatonin tablet as an adjunctive therapy in decreasing morbidity for pediatric patients diagnosed with Dengue Fever with Warning Signs at Ilocos Training and Regional Medical Center Department of Pediatrics.
Specific Objective
- To determine the clinical profiles of pediatric patients diagnosed with Dengue Fever with Warning Signs in Ilocos Training and Regional Medical Center
- To determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs with regards to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The research assistant will explain to the parents and to the child if capable of understanding the clinical trial. However, the participants, family and the researcher will not know until the end of the study if they were placed in the control group or treatment group. Blinding will be done using a pre-generated number code and QR code which, when scanned by the research assistant at the end of the study, it will reveal to what group the patient was randomized.
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 5 to 18 years old with febrile episodes (Temperature >/= 37.8 degrees Celsius) with positive Dengue NS
- •Patients with Dengue Fever on the Department of Health 2012 definition of Dengue fever with Warning Signs with any one of the following:
- •Abdominal tenderness
- •Persistent vomiting
- •Minimal mucosal bleed
- •Platelet count less than or equal to 100,000
排除标准
- •Patients with signs and symptoms related to dengue fever but with negative Dengue Ns1 result.
- •Patients diagnosed as Severe Dengue or Dengue Shock.
- •Patients unable to tolerate tablet formulation.
- •Patients placed on nothing per Orem.
- •Patients previously treated in a referring facility.
研究组 & 干预措施
Treatment Group
Other than the guided management of Dengue Fever with warning signs, the treatment group will receive a standard dose of 20mg/day of melatonin20-21 for 5 days. The dosing was based on the study by Leiberman et al and Malhotra et al. If a patient is unable to tolerate the whole or punctured tablet, it will be given with milk or water. There is no known interaction between melatonin and milk known to date. Daily complete blood count will be done and be recording in an electronic record using Microsoft Excel.
干预措施: Melatonin 20 MG (Drug)
结局指标
主要结局
Number Of Days Prior To Elevation of Platelet Count Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.
时间窗: 1 year
Effectiveness Of Melatonin Tablet As An Adjunctive Therapy In Decreasing Morbidity For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs
次要结局
- Number Of Days Prior To Elevation of White Blood Cells Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.(1 year)
- Incidence Of Dengue Fever with Warning Signs among Pediatric Population at Ilocos Training and Regional Medical Center.(1 year)
- determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs(1 year)
研究者
Navid Roodaki
Pediatric Chief Resident
Ilocos Training and Regional Medical Center