Health Condition 1: N771- Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
Conditions
Interventions
Intervention1: Colloidal Nano Silver Gel (SilverSol®): The dose is one 4 gm application inserted into the vagina once daily at bedtime for internal use and 2 gm gel for local application to vagina for
Sponsors
Viridis BioPharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postmenarchal female subjects between 18 to 65 years of age (Both Inclusive). 2. Subjects must have a confirmed clinical diagnosis of vaginal infection with any one, two or all of the following inclusion criteria- a) Diagnosis of bacterial vaginosis based on the presence of all four Amsel criteria.Homogeneous vaginal discharge (off white, milky or gray, thin), positive KOH whiff test,vaginal secretions,pH of > 4.5, Clue cells = 20 percent of vaginal squamous epithelial cells on saline wet mount. And/or b) Diagnosis of Vulvovaginal Candidiasis(VVC) demonstrating presence of yeast forms (hyphae or pseudohyphae) or budding yeasts on the KOH or saline preparation from the inflamed vaginal mucosa or secretions with two or more signs and symptoms of VVC and Vaginal pH less than or equal to 4.5.(Signs: edema, redness, or excoriation. Symptoms: itching, burning, and/or irritation) And/or c) Diagnosis of Trichomoniasis at the screening visit as determined by Positive wet mount assessment for Trichomonas vaginalis with any one of the symptoms (i.e. itching, discharge and odor). 3. Subjects who agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays,Spermicides, tampons, and diaphragms). 4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with other infectious causes of vulvovaginitis e.g Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex. 2. Presence of any condition or illness, including vulvar and vaginal conditions, that in the opinion of the investigator would preclude accurate evaluation of the subject’s condition and/or confound the interpretation of the subject’s treatment response. 3. Subject with history of cervical intra-epithelial neoplasia (CIN) or cervical carcinoma. 4. Subjects using systemic (oral, intravenous [IV], or intramuscular [IM]), intravaginal/ vulvovaginal antifungal, antimicrobial, or corticosteroid therapy within 14 days of participation in the study. 5. Subjects who are currently on any anticoagulation therapy or immunosuppressive therapy. 6. Pregnant, lactating, or planning to become pregnant during the study period. 7. Use of any investigational drug within 30 days of enrollment or plans to use other investigational products while enrolled in the study 8. History of hypersensitivity to Colloidal Silver or any other ingredient of the formulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving clinical cure at end of study Visit.Timepoint: 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving microbiological cure at end of study Visit.Timepoint: 15 days;The assessment of safety of Investigational Product will be based on the frequency of Adverse Events.Timepoint: 15 days | — |
Countries
India
Contacts
Public ContactDr Shashank S Jadhav
Biosphere Clinical Research Pvt.Ltd
Outcome results
None listed