A Randomized Controlled Trial to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- complete clearance of genital warts
研究概览
简要总结
The purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on genital warts. Our hypothesis is that there will be a 10% difference in complete clearance of genital warts in the group randomized to oral plus standard of care compared to those randomized to placebo plus standard of care.
详细描述
Clients presenting to the BCCDC STI clinic with genital warts will be randomized to either 400 mg zinc gluconate or placebo (200mg BID) for 8 weeks in addition to the standard of care. Clinical assessment of warts and additional standard treatment will occur every 7-10 days for a maximum of 8 weeks. A telephone call will occur at week 20 to determine if any of the warts have cleared or re-appeared. The appearance of new warts will also be noted. The proportion of subjects who have complete clearance of genital warts at 8 weeks will be compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 19 and over
- •Clinical diagnosis of genital warts requiring treatment based on clinician evaluation
- •Fluency in English
- •Available within four days of the intended 8 week follow-up visit
排除标准
- •Individuals under the age of 19
- •Pregnant women
- •Known contraindication to zinc Signs of copper/iron deficiency which include anemia and neutropenia which are characterized by tiredness, fatigue and light headedness.
- •Diseases that alter zinc metabolism or absorption eg. type II diabetes mellitus, Crohn's disease, chronic leg ulcers
- •Clients who are currently taking zinc for therapeutic purposes or have taken zinc in the last two months for therapeutic purposes
- •Clients who have received standard of care treatment for their warts in the past month
研究组 & 干预措施
Oral Zinc
干预措施: Oral Zinc (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
complete clearance of genital warts
时间窗: 8 weeks
次要结局
未报告次要终点