Bacterial VaginosisNCT06486103
A Clinical Study to Determine the Safety and Efficacy of an Oral Probiotic Supplementation to Improve Bacterial Vaginosis in Females
A study testing MetSheFlora - Vaginal Health in people with Bacterial Vaginosis, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- MetSheFlora - Vaginal Health
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 21 Oct 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is a healthy non-pregnant/non-lactating females aged 18 to 55 years.
- Subjects having refrigerator at their home for storage of test treatment.
- Presence of bacterial vaginosis (BV) as determined by gynaecological examination, including assessment for clinical symptoms such as abnormal vaginal discharge, malodour (moderate to very intense), and other relevant clinical indicators.
- The subject is willing to provide written informed consent and follow study procedures.
- The subject is willing to abide by the study protocol and restrictions, including abstaining from using any other intimate wash, lubricant, or treats during the study.
- The subject is willing to use a highly effective method of contraception throughout the clinical investigation. This includes:
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- Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
- Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, and agree to continue using the same contraception for the study duration.
- Agreement for gynaecological pelvic examination by a Gynaecologist.
- The subject is willing to abstain from sexual intercourse for a period of 24 hours before scheduled study visits to minimize potential interference with study assessments and measurements.
Who cannot join
- The subject has used hormone replacement therapy in the last 3 months.
- The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections, or urinary tract infections.
- The subject is pregnant/lactating, or are likely to become pregnant.
- The subject has been diagnosed with or reported gynaecologic abnormalities within 60 days prior to study initiation that may influence study results.
- The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
- The subject has chronic infection/allergy/disease that may influence study results.
Show all 11Show fewer
- The subject has participated in clinical studies or received any investigational agent in the previous 30 days.
- The subject has failed to satisfy the Investigator for fitness to participate for any other reason.
- The subject has not experienced previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
- The subject does not have vaginal prolapse and/or other medical conditions interfering with study conduct and participation.
- The subject has not used systemic and/or local hormonal products for vaginal dryness or any other vaginal condition in the 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
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:
- Visit 01 [Day 01]: Screening, baseline evaluations, enrolment and test treatment dispensing.
- Visit 02 [Day 15 (±2 days)]: Treatment Phase, Follow-up Evaluations.
- Visit 03 [Day 30 (±2 days)]: Treatment End, Final Evaluations.
- Conditions
- Bacterial Vaginosis
- Being tested
- MetSheFlora - Vaginal Health
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetSheFlora - Vaginal HealthOther
Take one slow-release capsule twice a day, after meal.
| Study group | Role | What they receive |
|---|---|---|
| Bacterial Vaginosis | Experimental | Take one slow-release capsule twice a day, after meal, orally. Receives: Other: MetSheFlora - Vaginal Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Secondary outcomes (38)
Change in vaginal pH
Assessment of the effectiveness of test treatment in terms of change in vaginal pH
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start21 Oct 2024
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An Open-Label, Single-Arm, Prospective Interventional Proof-of-Science Study.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Meteoric Biopharmaceuticals Pvt. Ltd.
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr. Nayan K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486103
- Sponsor's protocol ID
- NB240018-MB
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06486103
- Acronym / sponsor ID
- NB240018-MB
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Meteoric Biopharmaceuticals Pvt. Ltd.
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Visit 01 [Day 01]: Screening, baseline evaluations, enrolment and test treatment dispensing.
- Visit 02 [Day 15 (±2 days)]: Treatment Phase, Follow-up Evaluations.
- Visit 03 [Day 30 (±2 days)]: Treatment End, Final Evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An Open-Label, Single-Arm, Prospective Interventional Proof-of-Science Study.
| Arm | Type | Receives |
|---|---|---|
| Bacterial Vaginosis | Experimental | Other: MetSheFlora - Vaginal HealthTake one slow-release capsule twice a day, after meal, orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject is a healthy non-pregnant/non-lactating females aged 18 to 55 years.
- Subjects having refrigerator at their home for storage of test treatment.
- Presence of bacterial vaginosis (BV) as determined by gynaecological examination, including assessment for clinical symptoms such as abnormal vaginal discharge, malodour (moderate to very intense), and other relevant clinical indicators.
- The subject is willing to provide written informed consent and follow study procedures.
- The subject is willing to abide by the study protocol and restrictions, including abstaining from using any other intimate wash, lubricant, or treats during the study.
Key exclusion criteria (11 listed)
- The subject has used hormone replacement therapy in the last 3 months.
- The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections, or urinary tract infections.
- The subject is pregnant/lactating, or are likely to become pregnant.
- The subject has been diagnosed with or reported gynaecologic abnormalities within 60 days prior to study initiation that may influence study results.
- The subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetSheFlora - Vaginal HealthTake one slow-release capsule twice a day, after meal. | Other | Bacterial Vaginosis |
Primary outcome
Change in quality of vaginal discharge
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
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
change in odour of vaginal discharge.
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)
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.
Nugent score
Time frame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
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.
38 secondary outcomes
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
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
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (burning).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (stinging).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (moisture).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (flaking).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (epithelial mucosa).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (redness).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (dryness).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (odour).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (itching).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
Treatment-emergent adverse events (soreness of vulva ).
Time frame: On Day 15 (±2 days) and Day 30 (±2 days) post-dose.
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (Lymphocytes)
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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)
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
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
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including CBC (Serum Creatinine)
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Safety laboratory tests including Urinalysis
Time frame: On Day 01 before dosing, and on Day 30 (±2 days) post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nayan K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetSheFlora - Vaginal Health in people with Bacterial Vaginosis, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of vaginal discharge (time frame: On Day 01 (before administration) for baseline, and post-dose on Day 15 (±2 days) and Day 30 (±2 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.