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NCT05034809

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

Status unknown Phase 2 Last updated 13 October 2021
What this trial tests

Phase 2 trial testing Melatonin 20 MG in Dengue Fever With Warning Signs in 140 participants. Status unknown.

Timeline
20 October 2021
Primary endpoint
30 August 2022
30 October 2022

Quick facts

Lead sponsorIlocos Training and Regional Medical Center
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment140
Start date20 October 2021
Primary completion30 August 2022
Estimated completion30 October 2022

Drugs / interventions tested

Conditions studied

Sponsor

Ilocos Training and Regional Medical Center

Who can join

Adults 5 to 18, any sex, with Dengue Fever With Warning Signs. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Molecular Mechanisms of Antiviral Agents against Dengue Virus.
    Lee MF, Wu YS, Poh CL. · · 2023 · cited 66× · PMID 36992414 · DOI 10.3390/v15030705
  2. Inhibitory Potential of Chromene Derivatives on Structural and Non-Structural Proteins of Dengue Virus.
    Dharmapalan BT, Biswas R, Sankaran S, Venkidasamy B, et al · · 2022 · cited 7× · PMID 36560664 · DOI 10.3390/v14122656
  3. Orthoflaviviral Inhibitors in Clinical Trials, Preclinical In Vivo Efficacy Targeting NS2B-NS3 and Cellular Antiviral Activity via Competitive Protease Inhibition.
    Cavina L, Bouma MJ, Gironés D, Feiters MC. · · 2024 · cited 5× · PMID 39274895 · DOI 10.3390/molecules29174047
  4. A systematic mapping review of therapeutic clinical trials in dengue.
    Huyen TB, McBride A, Thein TL, Le KM, et al · · 2026 · PMID 42247469 · DOI 10.1371/journal.pntd.0014382

Verify or expand the search:

Other recruiting trials for Dengue Fever With Warning Signs

Currently open trials in the same condition.

Other Ilocos Training and Regional Medical Center trials

Trials by the same sponsor.

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