Melatonin Effects on Genital Herpes in Brazilian Women
- Conditions
- Genital Herpes
- Interventions
- Combination Product: Melatonin 3 mg
- Registration Number
- NCT03831165
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description melatonin 3mg + Acyclovir 400mg Melatonin 3 mg Group I - melatonin 3mg + Acyclovir 400mg melatonin 3mg + Acyclovir 400mg Acyclovir Group I - melatonin 3mg + Acyclovir 400mg placebo + melatonin 3mg Acyclovir Group III - placebo + melatonin 3mg Acyclovir 400mg Melatonin 3 mg Group II - Acyclovir 400mg twice a day Acyclovir 400mg Acyclovir Group II - Acyclovir 400mg twice a day placebo + melatonin 3mg Melatonin 3 mg Group III - placebo + melatonin 3mg
- Primary Outcome Measures
Name Time Method Clinical disease activity 2 years Number of participants with clinical signals of herpes genial activity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷Sao Paulo, Brazil
Avenida Doutor Eneas Carvalho de Aguiar 255 10 andar
🇧🇷São Paulo, SP, Brazil