A Comparative study on the efficacy of Oral Metronidazole VS Oral Metronidazole with ORAL Probiotics in the management of Bacterial Vaginosis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- clinical and microbiological cure
研究概览
简要总结
It is a Randomized Control Study. Patients satisfying the inclusion criteria will be included in the study. Patient socio demographic data and a thorough history will be taken. General examination, systemic examination, Genital examination under Cusco’s bivalve self-retaining vaginal speculum will be done. Genital discharge smears will be taken from the posterior fourchette and Vaginal discharge will be subjected for sniff test, whiff test, vaginal pH examination using litmus papers. Vaginal discharge will be investigated under saline mount, KOH examination, Gram staining of vaginal smear. After diagnosis of Bacterial vaginosis using Amsel’s criteria patients are randomized into two groups A and B ( randomization by Simple random sampling )
Group A:
Patients in this group will receive Oral Metronidazole 400 mg BD daily for 1 week
Group B:
Patients in this group will receive Oral Metronidazole 400mg BD daily for 1 week plus oral lactobacillus(containing Lactobacillus rhamnosus and Lactobacillus reuteri each 1 million colony forming units ) given twice daily for 4weeks, followed by once daily for next 4 weeks (total – 2months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient with more than 18 years of age Patient with complaints of vaginal discharge satisfying Amsel criteria Patient willing for consent, study and regular follow up Patient willing to take photograph.
排除标准
- •Patients below 18 years.
- •Patients with sexually transmitted diseases such as HIV , Syphilis, Hepatitis B and Hepatitis C Patient with vaginal discharge due to co-existing genital ulcer Patient with other infective causes of vaginal discharge such as Trichomonas vaginitis, vulvovaginal candidiasis Patients who are on treatment with any antibiotics 6 weeks prior to the study Lactating or Pregnant women.
结局指标
主要结局
clinical and microbiological cure
时间窗: 1 year
次要结局
- decreases the recurrences(1 year)
研究者
Soundharya G
Government Stanley Medical College