Melatonin Effects on Genital Herpes in Brazilian Women

January 5, 2022 updated by: University of Sao Paulo General Hospital

Effects of Melatonin in the Treatment of Genital Herpes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 .

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
    • SP
      • São Paulo, SP, Brazil, 05403000
        • Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 47 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

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

Exclusion criteria:

  • immunodeficiencies
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: melatonin 3mg + Acyclovir 400mg
Group I - melatonin 3mg + Acyclovir 400mg
Combination product: Melatonin 3 mg
melatonin and placebo
Drug: Acyclovir
Only acyclovir 200 mg twice a day
Active Comparator: Acyclovir 400mg
Group II - Acyclovir 400mg twice a day
Combination product: Melatonin 3 mg
melatonin and placebo
Drug: Acyclovir
Only acyclovir 200 mg twice a day
Placebo Comparator: placebo + melatonin 3mg
Group III - placebo + melatonin 3mg
Combination product: Melatonin 3 mg
melatonin and placebo
Drug: Acyclovir
Only acyclovir 200 mg twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical disease activity
Time Frame: 2 years
Number of participants with clinical signals of herpes genial activity
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Director: Edmund C Baracat, PhD, Universidade de Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2015

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

December 28, 2021

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1215208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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