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Melatonin Effects on Genital Herpes in Brazilian Women

U

University of Sao Paulo General Hospital

Status and phase

Completed
Phase 4

Conditions

Genital Herpes

Treatments

Combination Product: Melatonin 3 mg
Drug: Acyclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT03831165
1215208

Details and patient eligibility

About

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.

Full 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 .

Enrollment

90 patients

Sex

Female

Ages

15 to 49 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • immunodeficiencies
  • pregnant women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

90 participants in 3 patient groups, including a placebo group

melatonin 3mg + Acyclovir 400mg
Experimental group
Description:
Group I - melatonin 3mg + Acyclovir 400mg
Treatment:
Combination Product: Melatonin 3 mg
Drug: Acyclovir
Acyclovir 400mg
Active Comparator group
Description:
Group II - Acyclovir 400mg twice a day
Treatment:
Combination Product: Melatonin 3 mg
Drug: Acyclovir
placebo + melatonin 3mg
Placebo Comparator group
Description:
Group III - placebo + melatonin 3mg
Treatment:
Combination Product: Melatonin 3 mg
Drug: Acyclovir

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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