Melatonin Effects on Genital Herpes in Brazilian Women

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Effects of Melatonin in the Treatment of Genital Herpes

Conditions
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Genital Herpes

Intervention / Treatment
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* Combination Product: Melatonin 3 mg
* Drug: Acyclovir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: clinical and laboratory diagnosis of genital herpes real time polymerase chain reaction for herpes type 2 serology Exclusion criteria: immunodeficiencies pregnant women

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acyclovir, melatonin