A clinical trial to study the effects of evaluation of efficacy and safety of Fermalac Intravaginal Capsule (Lactobacillus Rhamnosus, Lactobacillus Delbrueckii, Streptococcus Thermophilus) in the treatment of Bacterial Vaginosis among the Indian wome
- Registration Number
- CTRI/2009/091/000919
- Lead Sponsor
- Arun & Co.603 / B Polaris, Off Marol Maroshi Road,Behind Sangeet Plaza, Marol,Andheri (East), Mumbai - 400059India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the recurrence rate of vaginal infections (by clinical & microbiological evaluation)Timepoint: At baseline, day 7 and 14.
- Secondary Outcome Measures
Name Time Method 1. To observe change in total score of signs & symptoms<br>2. To evaluate the safety and tolerability of treatment<br>3. To assess the overall global improvementTimepoint: At Baseline, Day 7 and 14.