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 women

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000919

Enrollment

200

Registered

2010-01-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fermalac Intravaginal Capsule: One capsule per day for two weeks Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To evaluate the recurrence rate of vaginal infections (by clinical & microbiological evaluation)Timepoint: At baseline, day 7 and 14.	—

Secondary

Measure	Time frame
1. To observe change in total score of signs & symptoms 2. To evaluate the safety and tolerability of treatment 3. To assess the overall global improvementTimepoint: At Baseline, Day 7 and 14.	—

Countries

India

Contacts

Public ContactMr. D.M.Doshi

slsharma@zytex.net02267723000

Outcome results