Health Condition 1: N76- Other inflammation of vagina and vulva
Conditions
Interventions
Intervention1: Laphre: vaginal pessary containing two probiotic strains, with each capsule to contain 2 billion cfu of Lactobacillus rhamnosus UBLR-58 and Lactobacillus gasseri UBLG-36
Control Interve
Sponsors
Tenshi Life Care Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult, post-menarchal, pre-menopausal women aged 18 years or older 2. Diagnosis of bacterial vaginosis according to Amsels criteria, defined as having at least 3 of the 4 following criteria a)Thin, white, yellow, homogenous discharge b) Clue cells on microscopy (more than 20 percent of epithelial cells) c) pH of vaginal fluid above 4.5 d) Release of fishy odor i.e. a positive whiff test when alkali (10 percent potassium hydroxide solution is added 3. Having decisional capacity and providing written informed consent 4. Negative urine pregnancy test at screening 5. Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period 6. Refrain from sexual intercourse or use a condom until Day 7 7. Signed informed consent and willing and able to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoea, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening 2. Anticipated menstruation during the treatment period (Day 0 till Day 7) 3. Patients who are pregnant or breastfeeding 4. Patients who were treated for bacterial vaginosis within the past 14 days 5. Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days 6. Patients who have used pH modifying vaginal products within the last 14 days 7. Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening 8. Known or previous allergy or hypersensitivity to any product constituent 9.Any medical condition that in the Investigator judgments would make the patient unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study would give an understanding of how the formulation Laphre - vaginal pessary is effective for treating bacterial vaginosis.Timepoint: Two months | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical observations would help in design and conduct of clinical trials of this formulation for treatment of Bacterial Vaginosis.Timepoint: Two months | — |
Countries
India
Contacts
Public ContactDr Sivakumar Vijayaraghavalu
Narayana Medical College
Outcome results
None listed