NCT05034809

Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Dengue Fever With Warning Signs

Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs: A Randomized Control Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Ilocos Training and Regional Medical Center · Other Government
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 1. To determine the clinical profiles of pediatric patients diagnosed with Dengue Fever with Warning Signs in Ilocos Training and Regional Medical Center 2. To determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs with regards to: a. Number of days for resolution of fever from the 1st day of administration of melatonin b. Number of days for the platelet count to increase from the 1st day of administration of melatonin c. Number of days for the white blood cell count to increase from the 1st day of administration of melatonin d. Absence of subsequent complications in the critical phase of the illness (4th - 6th day of illness) i. Presence of mucosal bleeding, melena, epistaxis ii. Presence of ascites, pleural effusion, edema iii. Hypotension, tachycardia iv. Increase capillary refill time

Conditions

• Dengue Fever With Warning Signs

Interventions

Type	Name	Description
DRUG	Melatonin 20 MG	Melatonin, also known as N-acetyl-5-methoxytryptamine will be the main intervention given to participating patients of this study. This study will use a dose of 20mg/day using the commercially available 5mg/tablet20-21. If a patient cannot be tolerate swallowing the whole tablet, it will be crushed and mixed with milk. According to the study done by Shah et al. there was no degradation in the active component of melatonin when mixed with milk or food as a medium for drug delivery.

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-08-30
• Completion: 2022-10-30
• First posted: 2021-09-05
• Last updated: 2021-10-13