Melatonin Effects on Genital Herpes in Brazilian Women

Genital Herpes Clinical Trial

Official title:

Effects of Melatonin in the Treatment of Genital Herpes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831165
• Other study ID #: 1215208
• Status: Completed
• Phase: Phase 4
• Start date: September 2, 2015
• Est. completion date: December 28, 2021

Study information

• Verified date: January 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The authors have investigate the relationship of estrogen-dependent malignant tumors with reduced levels of melatonin. It is speculated that the indoleamine can be classified as anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and by its interference with estrogen receptors. Experimentally melatonin prevents promotion and growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor; increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase activity in tumor cells .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 28, 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion criteria:

• clinical and laboratory diagnosis of genital herpes
• real time polymerase chain reaction for herpes type 2
• serology

Exclusion criteria:

• immunodeficiencies
• pregnant women

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Combination Product:
• Melatonin 3 mg
melatonin and placebo

Drug:
• Acyclovir
Only acyclovir 200 mg twice a day

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo
Brazil	Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical disease activity	Number of participants with clinical signals of herpes genial activity	2 years