A Prospective, Randomized, Double blind, parallel group, Placebo controlled clinical study of capsule containing lactobacillus strains in adult women subjects suffering from BacterialVaginosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of IP in cases of bacterial vaginosis
研究概览
简要总结
This is Prospective, Randomized, Double blind, parallelgroup, Placebo controlled clinical study of capsule containing lactobacillusstrains in adult women subjects suffering from Bacterial Vaginosis.
Adult female subjects will be screened for presencebacterial vaginosis using Amsel’s criteria after obtaining written informedconsent. Eligible subjects will be randomized to either of the two groups –Group 1 (Test group) or Group 2 (Placebo group) using computer generatedrandomization schedule. Enrolled subjects will be provided capsules for dailyconsumption for 4 weeks according to their randomization sequence along withthe instructions of use. Safety and efficacy assessment will be done on day 7,14, 28, 42 and 56. Investigational product compliance will be checked on days7, 14 and 28 by counting the number of capsules consumed and time since lastvisit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Symptoms of vaginal discharge with Bacterial Vaginosis diagnosed by Amsel’s criteria.
- •Asymptomatic but on clinical examination presence of abnormal vaginal discharge with Bacterial Vaginosis diagnosed by Amsel’s criteria.
- •Willing to participate in the study after informed consent.
排除标准
- •1.Menopausal women 2.Pregnant women 3.Malignancy of reproductive tract 4.Less than 6 weeks since last delivery and abortion 5.H/O severe allergic reaction 6.Immuno compromised state.
结局指标
主要结局
To evaluate the efficacy of IP in cases of bacterial vaginosis
时间窗: 4 weeks
次要结局
- To evaluate the safety of IP in cases of bacterial vaginosis(4 weeks)