Studying the Role of N-Acetyl Cysteine Either Alone or in Combination With Metronidazole in Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- recovery of BV
研究概览
简要总结
N-Acetyl cysteine (NAC) is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.Its effect in biofilms has been tested in several bacteria. Biofilms have recently been observed in 90% of subjects with bacterial vaginosis (BV) with Gardnerella vaginalis being the predominant species. Although a wide range of antimicrobial agents are currently available, treatment options for controlling BV are still limited. Furthermore, the number of relapses are increasing and require alternative treatments. This study is aiming to evaluate the role of NAC in treatment of BV and prevention of recurrence.
详细描述
Bacterial vaginosis (BV) is the most frequent diagnosis made in women with lower genital tract symptoms. It has recently been observed that 90% of subjects with BV show the growth of bacteria in the form of biofilms,and that Gardnerella vaginalis was the predominant species. The propensity of G. vaginalis to form biofilm is clinically relevant because this form of growth allows it to tolerate higher concentrations of certain antibiotics, thus increasing the possibility of recurrent BV even after apparently curative therapy. So new treatment strategies must be used to insure complete cure and prevent recurrence. NAC is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.Its effect in biofilms has been tested in several bacteria.
This study aims to test the efficacy of NAC in treatment of BV either alone or in combination with the traditionally used metronidazole. Also the effect of using NAC in prevention of recurrence of BV will be monitored.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients complaining bacterial vaginosis and proved to have BV using standard diagnostic methods for BV
- •patients with age between 20-50
排除标准
- •Virgins and menstruating patients.
- •Recent douching or sexual intercourse.
- •Use of systematic or vaginal antimicrobial therapy or any vaginal suppositories or drugs.
- •All patients will sign a written consent before starting the treatment
研究组 & 干预措施
Metronidazole + N-Acetyl cysteine
the second patient group will use NAC sachets containing 200 mg as a vaginal douche once daily plus oral metronidazole 500 mg twice daily for 7 days
干预措施: Metronidazole + N-Acetyl cysteine (Drug)
N- Acetyl cysteine
the third patient group will use NAC sachets containing 200 mg as a vaginal douche only without taking metronidazole
干预措施: N-Acetyl cysteine (Drug)
Metronidazole
the first group of patients will take oral metronidazole 500 mg twice daily for a week
干预措施: metronidazole (Drug)
结局指标
主要结局
recovery of BV
时间窗: one week
Vaginal swabs from all patients will taken and smears will be gram stained, examined and evaluated according to Nugent scoring system afetr one week of treatment. The patient will be considered recovered if she have Nugent score of 0-3.
次要结局
- prevention of recurrence(3 months)
研究者
Heba Ahmed Mohamed
principal investigator
Minia University