Clinical trial NCT03831165: Melatonin Effects on Genital Herpes in Brazilian Women
Official title: Effects of Melatonin in the Treatment of Genital Herpes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Genital Herpes
Keywords: acyclovir
melatonin
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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 .

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

* immunodeficiencies
* pregnant women

Primary outcomes:
measure: Clinical disease activity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: Universidade de Sao Paulo General Hospital
name: Edmund C Baracat, PhD
role: STUDY_DIRECTOR
References: