CTRI/2009/091/000919已完成3 期
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
Arun & Co.603 / B Polaris, Off Marol Maroshi Road,Behind Sangeet Plaza, Marol,Andheri (East), Mumbai - 400059India0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female patients aged 21-35 years.
- •2. Non pregnant females
- •3. 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)
- •4. Female patients on adequate contraceptive control.
- •5. Written informed consent by patient.
- •6. Patient willing to follow up.
- •7. Restoration of beneficial microflora
排除标准
- •1. Pregnant and nursing women.
- •2. Mixed vaginal infections, including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis.
- •3. Abnormal papanicolaou smear (grade 3 or more) in the preceding 12 months
- •4. Patients who had taken oral or intravenous antifungal agents within 4 weeks or used topical vaginal antifungal drugs within 1 week before enrollment.
- •5. History of diabetes mellitus.
- •6. Immunocompromised patients, including those with known human immunodeficiency virus seropositivity or with clinically diagnosed acquired immunodeficiency syndrome or its related complex.
- •7. 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.
- •8. Patients who have participated in a new drug study in the past 3 months.
- •9. Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.
研究者
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