CTRI/2022/01/039560
Completed
未知
A Pilot Study to Evaluate the Efficacy and Safety of VagiBIOM Suppositories on Vaginal Health and pH.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vedic Lifesciences Pvt Ltd
- Enrollment
- 69
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Non\-pregnant, non\-breastfeeding females between the ages of 40 and 65 years, inclusive.
- •2\. Participants having at least 3 out of following symptoms or signs:
- •2\.1 Homogeneous, thin, white discharge that smoothly coats the vaginal walls;
- •2\.2 Presence of the clue cells on microscopic examination (as assessed by wet mount test)
- •2\.3 pH of vaginal fluid ââ?°Â¥5
- •2\.4 A fishy odor of vaginal discharge.
- •3\. Participants with Nugent score of ââ?°Â¥ 7\.
- •4\. Participants with a total Vaginal Health Index (VHI) score \<15\.
- •5\. Participants with pH ââ?°Â¥ 5\.
- •6\. Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.
Exclusion Criteria
- •1\. Participants with signs or symptoms of vaginal/cervical/pelvic/ urinary infection on screening or clinical diagnosis of vaginal/cervical/pelvic/ urinary infection in the past 14 days (including but not limited to yeast vulvovaginitis, chlamydia, gonorrhea, trichomonas, genital ulcer disease, pelvic inflammatory disease).
- •2\. Participants who are undergoing Hormone Replacement Therapy (HRT).
- •3\. Participants on prebiotics or probiotics in the last 1 month.
- •4\. Participants who are currently using antibiotics.
- •5\. Participants with history/ signs of cervical or vaginal high grade squamous intraepithelial dysplasia (HSIL), atypical glandular cells of uncertain significance (AGUS) or cervical intraepithelial neoplasia.
- •6\. Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system.
- •7\. Participants who have been diagnosed with polycystic ovary syndrome (PCOS).
- •8\. Uncontrolled type II diabetes mellitus (assessed by RBS ââ?°Â¥140 mg/dL.)
- •9\. Use of an immunosuppressive or immunomodulatory drug within 6 months prior to enrolment.
- •10\. Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) ââ?°Â¥ 140 mm Hg and/or diastolic blood pressure (DBP) ââ?°Â¥ 90 mm Hg).
Outcomes
Primary Outcomes
Not specified
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