Genital Herpes
Conditions
Keywords
acyclovir, melatonin
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 .
Interventions
COMBINATION_PRODUCTMelatonin 3 mg
melatonin and placebo
DRUGAcyclovir
Only acyclovir 200 mg twice a day
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical disease activity | 2 years | Number of participants with clinical signals of herpes genial activity |
Countries
Brazil
Outcome results
None listed