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

• Status: Not yet recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ilocos Training and Regional Medical Center
• Treatments: Melatonin

Criteria

Inclusion Criteria:

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

2. Patients with Dengue Fever on the Department of Health 2012 definition of Dengue fever with Warning Signs with any one of the following:

1. Abdominal tenderness

2. Persistent vomiting

3. Minimal mucosal bleed

4. Platelet count less than or equal to 100,000

Exclusion Criteria:

• 1. Patients with signs and symptoms related to dengue fever but with negative Dengue Ns1 result.

2. Patients diagnosed as Severe Dengue or Dengue Shock. 3. Patients unable to tolerate tablet formulation. 4. Patients placed on nothing per Orem. 5. Patients previously treated in a referring facility.