drugset / Trial / NCT03831165

Melatonin Effects on Genital Herpes in Brazilian Women

NCT03831165

Phase 4 Completed 90 enrolled University of Sao Paulo General Hospital
RandomizedCrossoverTriple-blindTreatment

Summary

Genital herpes is a common and increasingly-common infection worldwide. The annual incidence in the United States is 1.75 per 1000 inhabitants. The etiologic agent is the herpes type 1 and 2 strains simplex virus. Classical Treatment is with acyclovir which decreases the duration of the disease and prevents rashes but has no curative effect. Also, studies show herpes resistance to acyclovir which has stimulating research into new drugs to treat this condition. Authors suggest melatonin way be a therapeutic agent in herpetic disease due to its modulatory action in immune and inflammatory responses when administered in adequate doses. Therefore, the aim of this study is to evaluate the effects of melatonin in the treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective and randomized, investigation. Outcome measures will include clinical evaluation of patients and laboratory endpoints.

Timeline

Start
2015-09-02
Primary completion
2021-09
Completion
2021-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Acyclovir Small molecule 200 mg
Subject Acyclovir Small molecule 400 mg
Subject Melatonin Small molecule 3 mg
Subject Melatonin Small molecule 30 mg

Indications