A prospective, non - comparative and multi centric trial to evaluate the efficacy and safety of Fermalac Intravaginal Capsule (Lactobacillus Rhamnosus, Lactobacillus Delbrueckii, Streptococcus Thermophilus) in the treatment of Bacterial Vaginosis among the Indian women
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- To evaluate the recurrence rate of vaginal infections (by clinical & microbiological evaluation)
研究概览
简要总结
The study is A prospective, non - comparative and multi centric trial to evaluate the Efficacy and Safety of Fermalac intravaginal capsule (Lactobacillus Rhamnosus, Lactobacillus Delbrukii, and Streptococcus Thermophilus) in the treatment of bacterial vaginosis among the Indian Women for 14 days in 240 patients that will be conducted in four centers in India. The primary outcome measure will be to evaluate the recurrence rate of vaginal infections (by clinical & microbiological evaluation). The secondary outcome measure will be1. To observe change in total score of signs & symptoms2. To evaluate the safety and tolerability of treatment3. To assess the overall global improvement
研究设计
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
入选标准
- •Female patients aged 21-35 years.
- •Non pregnant females
- •Patients with an acute symptomatic episode of vaginal infection satisfying the following clinical and laboratory criteria- Presence of symptoms such as pruritus, dysuria, irritation, soreness, altered discharge and signs of vulvovaginal inflammation (edema, erythema & vulvar excoriation)
- •Female patients on adequate contraceptive control.
- •Written informed consent by patient.
- •Patient willing to follow up.
- •Restoration of beneficial microflora.
排除标准
- •Pregnant and nursing women.
- •Mixed vaginal infections, including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis.
- •Abnormal papanicolaou smear (grade 3 or more) in the preceding 12 months
- •Patients who had taken oral or intravenous antifungal agents within 4 weeks or used topical vaginal antifungal drugs within 1 week before enrollment.
- •History of diabetes mellitus.
- •Immunocompromised patients, including those with known human immunodeficiency virus seropositivity or with clinically diagnosed acquired immunodeficiency syndrome or its related complex.
- •Terminally ill patients or patients with severe cardiac, hepatic (ASAT, ALAT values >3 X upper limit of normal laboratory values) renal (creatinine clearance < 20ml/min) or cerebrovascular disease, malignancy, chronic uncontrolled systemic disease e.g. hypertension, collagen disorders, etc or any other serious medical illness.
- •Patients who have participated in a new drug study in the past 3 months.
- •Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.
结局指标
主要结局
To evaluate the recurrence rate of vaginal infections (by clinical & microbiological evaluation)
时间窗: At baseline, day 7 and 14.
次要结局
- 1. To observe change in total score of signs & symptoms2. To evaluate the safety and tolerability of treatment3. To assess the overall global improvement(At Baseline, Day 7 and 14.)