An interventional study of MetSheFlora - Vaginal Health in Bacterial Vaginosis, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Treatment
A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Enhancing Vaginal Health in Females with Mild to Moderate Bacterial Vaginosis: An Open-Label, Single-Arm, Prospective Interventional Proof-of-Science Study.
Total 14 healthy female patients aged 18 to 55 years with mild to moderate bacterial vaginosis will be enrolled to ensure 12 subjects complete the study.
Potential subjects will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent. The subject recruitment department will contact the potential subjects via telephone before the enrolment visit to confirm their participation.
Subjects shall be instructed to visit the facility for the following scheduled visits:
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 14 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →NovoBliss Research Pvt Ltd is the lead sponsor of 45 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The subject is willing to use a highly effective method of contraception throughout the clinical investigation. This includes:
Exclusion Criteria:
Take one slow-release capsule twice a day, after meal, orally.
Other: MetSheFlora - Vaginal Health
Take one slow-release capsule twice a day, after meal.
Change in quality of vaginal discharge
Assessment of the effectiveness of test treatment in terms of change in quality of vaginal discharge using 5 point scoring scale where 0 indicate absent and 4 indicates very intense
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
change in odour of vaginal discharge.
Assessment of the effectiveness of test treatment in terms of change in odour of vaginal discharge using 5 point scoring scale where 0 indicate absent and 4 indicates very intense.
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
Nugent score
Assessment of the effectiveness of test treatment in terms of change in Nugent score where 0-3 indicates normal, 4-6 indicates intermediate bacterial count and 7-10 indicates bacterial vaginosis.
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Change in vaginal pH
Assessment of the effectiveness of test treatment in terms of change in vaginal pH
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days),
Change in VAS score
Assessment of the effectiveness of test treatment in terms of change in VAS score for vaginal itching where 0= indicates no itch and 10 indicates severe itch
Time frame: On Day 01 (before application) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days).
Subject's perception
Assessment of the subject's perception regarding the test treatment using a hedonic scale questionnaire for parameters such as smell, taste, overall palatability, perceived effectiveness.
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (burning).
Assessment of safety of test treatment through treatment-emergent adverse events such as burning.
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (stinging).
Assessment of safety of test treatment through treatment-emergent adverse events such as stinging using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (moisture).
Assessment of safety of test treatment through treatment-emergent adverse events such as moisture using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (flaking).
Assessment of safety of test treatment through treatment-emergent adverse events such as flaking using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (epithelial mucosa).
Assessment of safety of test treatment through treatment-emergent adverse events such as epithelial mucosa using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (redness).
Assessment of safety of test treatment through treatment-emergent adverse events such as redness using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (dryness).
Assessment of safety of test treatment through treatment-emergent adverse events such as dryness.
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (odour).
Assessment of safety of test treatment through treatment-emergent adverse events such as odour using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (itching).
Assessment of safety of test treatment through treatment-emergent adverse events such as itching using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (soreness of vulva ).
Assessment of safety of test treatment through treatment-emergent adverse events such as soreness of vulva using scoring scale 0= Indicate absent and 3= severe
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Safety laboratory tests including Haemoglobin
Assessment of safety of test treatment through the performance of safety laboratory tests including Haemoglobin
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Haematocrit
Assessment of safety of test treatment through the performance of safety laboratory tests including Haematocrit
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including RBC count
Assessment of safety of test treatment through the performance of safety laboratory tests including RBC count
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including packed cell volume
Assessment of safety of test treatment through the performance of safety laboratory tests including packed cell volume
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including RBC morphology
Assessment of safety of test treatment through the performance of safety laboratory tests including RBC morphology
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean corpuscular volume
Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular volume
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean corpuscular hemoglobin
Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular hemoglobin
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean corpuscular haemoglobin concentration
Assessment of safety of test treatment through the performance of safety laboratory tests including mean corpuscular haemoglobin concentration
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Red blood cell distribution width
Assessment of safety of test treatment through the performance of safety laboratory tests including Red blood cell distribution width
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Neutrophils
Assessment of safety of test treatment through the performance of safety laboratory tests including Neutrophils
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (Lymphocytes)
Assessment of safety of test treatment through the performance of safety laboratory tests including Lymphocytes
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Eosinophils
Assessment of safety of test treatment through the performance of safety laboratory tests including Eosinophils
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Monocyte
Assessment of safety of test treatment through the performance of safety laboratory tests including Monocyte
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Basophils
Assessment of safety of test treatment through the performance of safety laboratory tests including Basophils
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Platelet count
Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet count
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including mean platelet volume
Assessment of safety of test treatment through the performance of safety laboratory tests including mean platelet volume
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including plateletcrit
Assessment of safety of test treatment through the performance of safety laboratory tests including plateletcrit
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Platelet Distribution Width
Assessment of safety of test treatment through the performance of safety laboratory tests including Platelet Distribution Width
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including random blood sugar
Assessment of safety of test treatment through the performance of safety laboratory tests including random blood sugar
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Total serum cholesterol
Assessment of safety of test treatment through the performance of safety laboratory tests including Total serum cholesterol
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (triglyceride)
Assessment of safety of test treatment through the performance of safety laboratory tests including triglyceride
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including high-density lipoprotein
Assessment of safety of test treatment through the performance of safety laboratory tests including high-density lipoprotein
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including low-density lipoprotein
Assessment of safety of test treatment through the performance of safety laboratory tests including low-density lipoprotein
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (Serum Creatinine)
Assessment of safety of test treatment through the performance of safety laboratory tests including Serum Creatinine
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Urinalysis
Assessment of safety of test treatment through the performance of safety laboratory tests including Urinalysis
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Plan to share: No
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