Effects of Melatonin in the Treatment of Genital Herpes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Clinical disease activity
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
melatonin 3mg + Acyclovir 400mg
Group I - melatonin 3mg + Acyclovir 400mg
干预措施: Melatonin 3 mg (Combination Product)
melatonin 3mg + Acyclovir 400mg
Group I - melatonin 3mg + Acyclovir 400mg
干预措施: Acyclovir (Drug)
Acyclovir 400mg
Group II - Acyclovir 400mg twice a day
干预措施: Melatonin 3 mg (Combination Product)
Acyclovir 400mg
Group II - Acyclovir 400mg twice a day
干预措施: Acyclovir (Drug)
placebo + melatonin 3mg
Group III - placebo + melatonin 3mg
干预措施: Melatonin 3 mg (Combination Product)
placebo + melatonin 3mg
Group III - placebo + melatonin 3mg
干预措施: Acyclovir (Drug)
结局指标
主要结局
Clinical disease activity
时间窗: 2 years
Number of participants with clinical signals of herpes genial activity
次要结局
未报告次要终点