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

Who is this study for? Pediatric patients with dengue fever with warning signs
What treatments are being studied? Melatonin
Status: Not yet recruiting
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2

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.

Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: No

• Patient aged 5 to 18 years old with febrile episodes (Temperature >/= 37.8 degrees Celsius) with positive Dengue NS1.

• 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

Contact Information
Navid P Roodaki, MD
+63 917 309 3931
Time Frame
Start Date: October 20, 2021
Estimated Completion Date: October 30, 2022
Target number of participants: 140
Experimental: 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.
No Intervention: Control Group
Other than the guided management of Dengue Fever with warning signs, the control group will be manage according the Department of Health Dengue Management Guideline. No placebo will be given.
Related Therapeutic Areas
Leads: Ilocos Training and Regional Medical Center

This content was sourced from clinicaltrials.gov

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