A clinical study of Colloidal Nano Silver Gel in the treatment of vaginal infections

Phase 2

Completed

Conditions: Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere,

Brief Summary: This study is A Phase II, Multicentre, Randomized, Double blind, Placebo controlled Clinical Study to evaluate the Efficacy and Safety of Colloidal Nano Silver Gel (SilverSolÂ®) in the treatment of Bacterial Vaginosis, Vulvovaginal Candidiasis and Trichomoniasis

The objective is to evaluate the efficacy an safety of Colloidal Nano Silver Gel (SilverSolÂ®) in the treatment of Bacterial Vaginosis, Vulvovaginal Candidiasis and Trichomoniasis.

Primary Endpoint:

-Proportion of subjects achieving clinical cure at end of study Visit.

Secondary Endpoint

Proportion of subjects achieving microbiological cure at end of study Visit.

Recruitment & Eligibility

Inclusion Criteria

Postmenarchal female subjects between 18 to 65 years of age (Both Inclusive).
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 â‰¥ 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).
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).
Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion Criteria

Subjects with other infectious causes of vulvovaginitis e.g Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex.
Presence of any condition or illness, including vulvar and vaginal conditions, that in the opinion of the investigator would preclude accurate evaluation of the subjectâ€™s condition and/or confound the interpretation of the subjectâ€™s treatment response.
Subject with history of cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
Subjects using systemic (oral, intravenous [IV], or intramuscular [IM]), intravaginal/ vulvovaginal antifungal, antimicrobial, or corticosteroid therapy within 14 days of participation in the study.
Subjects who are currently on any anticoagulation therapy or immunosuppressive therapy.
Pregnant, lactating, or planning to become pregnant during the study period.
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.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving clinical cure at end of study Visit.	15 days

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving microbiological cure at end of study Visit.	15 days
The assessment of safety of Investigational Product will be based on the frequency of Adverse Events.	15 days

Locations (3): Akshay Surgrical and Maternity Home
🇮🇳
Thane, MAHARASHTRA, India
Prarthna Clinic
🇮🇳
Pune, MAHARASHTRA, India
Titan Hospital
🇮🇳
Thane, MAHARASHTRA, India
Akshay Surgrical and Maternity Home
🇮🇳Thane, MAHARASHTRA, India
Dr Alaka Godbole
Principal investigator
9833967970
godbole369@gmail.com