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Melatonin Effects on Genital Herpes in Brazilian Women

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03831165
Collaborator
(none)
90
Enrollment
2
Locations
3
Arms
75.9
Actual Duration (Months)
45
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The patients will be divided into three groups. One group (group A) will receive a bottle with 360 pills of acyclovir 200 mg. These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days. Group B will receive 90 tablets of 30 mg of melatonin, the tablet will be used as 01 tablet daily for 90 days. Group C will receive 90 tablets of melatonin 3mg, and 360 tablets of acyclovir dose is 1 tablet per day for 90 days.The patients will be divided into three groups. One group (group A) will receive a bottle with 360 pills of acyclovir 200 mg. These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days. Group B will receive 90 tablets of 30 mg of melatonin, the tablet will be used as 01 tablet daily for 90 days. Group C will receive 90 tablets of melatonin 3mg, and 360 tablets of acyclovir dose is 1 tablet per day for 90 days.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
The patients will be treated at the Clinic of Gynecology, University of Sao Paulo during a total of 04 visits. In the first and fourth visits, patients will be sent to the laboratory of the University Hospital for collecting the cluster of differentiation 4 cells, interleukin-2 and serology for herpes.
Primary Purpose:
Treatment
Official Title:
Effects of Melatonin in the Treatment of Genital Herpes
Actual Study Start Date :
Sep 2, 2015
Actual Primary Completion Date :
Sep 1, 2021
Actual Study Completion Date :
Dec 28, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Clinical disease activity [2 years]

    Number of participants with clinical signals of herpes genial activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • clinical and laboratory diagnosis of genital herpes

  • real time polymerase chain reaction for herpes type 2

  • serology

Exclusion criteria:

  • immunodeficiencies

  • pregnant women

Contacts and Locations

Locations

Site City State Country Postal Code
1 Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar São Paulo SP Brazil 05403000
2 Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Sao Paulo Brazil 05403000

Sponsors and Collaborators

  • University of Sao Paulo General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT03831165
Other Study ID Numbers:
  • 1215208
First Posted:
Feb 5, 2019
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by University of Sao Paulo General Hospital
acyclovir
melatonin
Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis
Acyclovir
Melatonin

Study Results

No Results Posted as of Jan 11, 2022