Bacterial VaginosisPhase 4NCT05060029
A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH
A Phase 4 study testing Lactobacillus Species in people with Bacterial Vaginosis, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
Trial summary
Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G. vaginalis and other microbes without affecting lactobacilli. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lactobacillus Species
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 5 sitesIndia
- Study dates
- 3 Jan 2022to 12 Aug 2022
- Phase
- Phase 4
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant, non-breastfeeding females between the ages of 40 and 65 years, inclusive.
- Participants having at least 3 out of following symptoms or signs:
- Homogeneous, thin, white discharge that smoothly coats the vaginal walls.
- Presence of the clue cells on microscopic examination (as assessed by wet mount test)
- pH of vaginal fluid ≥5
- A fishy odor of vaginal discharge.
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- Participants with Nugent score of ≥ 7.
- Participants with a total Vaginal Health Index (VHI) score <15.
- Participants with pH ≥ 5.
- Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.
- Participants able to comply with and perform the procedures requested by the protocol (including IP compliance, blood sample collection procedures and study visit schedule).
- Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
- Participants able to give written informed consent and willingness to participate in the study and comply with its procedures.
Who cannot join
- Participants with signs or symptoms of vaginal or cervical or pelvic or 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).
- Participants who are undergoing Hormone Replacement Therapy (HRT).
- Participants on prebiotics or probiotics in the last 1 month.
- Participants who are currently using antibiotics.
- 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.
- Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system.
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- Participants who have been diagnosed with polycystic ovary syndrome (PCOS).
- Uncontrolled type II diabetes mellitus (assessed by RBS ≥140 mg/dL.)
- Use of an immunosuppressive or immunomodulatory drug within 6 months prior to enrolment.
- Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg).
- Abnormal Thyroid Stimulating Hormone (TSH) value out of reference range of 0.35 to 5.00 μIU/mL.
- History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- Participation in other clinical trials in last 3 months prior to screening.
- Smokers (Past smokers can be allowed if they have abstinence for minimum 2 years).
- Chronic or sporadic abdominal pain including moderate to severe dysmenorrhoea.
- Substance abuse problems (within 2 years) defined as:
- Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women.
- Any of the following clinically significant illness, i.e. Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.
- History of hepatitis B/ hepatitis C/ HIV infection.
- Regular medical treatment including over the counter medication, which may have impact on the study aims (e.g., probiotics, antibiotic drugs, laxatives etc.)
- Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites, 5 recruiting
- Recruiting
JNU Institute for Medical Sciences and Research
Jaipur, Maharashtra, 302017
Dr. Kamlesh Kumari, MS (OBSTETRICS & GYNECOLOGY), 7615931030, clinicalresearch@jnujaipur.ac.in
Dr. Kamlesh Kumari, MS (OBSTETRICS & GYNECOLOGY)
- Not yet recruiting
Shinde Medicare Hospital
Mumbai, Maharashtra, 400058
Dr. Veena Shinde, MD, DGO, 9821225392, drveenashinde@gmail.com
Dr. Veena Shinde, MD, DGO
- Not yet recruiting
Saraogi Hospital
Mumbai, Maharashtra, 400064
Dr. R.M. Saraogi, MD, DGO, 9820146689, drsaraogi@hotmail.com
Dr. R.M. Saraogi, MD, DGO
- Recruiting
Shreenika Hospital
Thane, Maharashtra, 400605
Dr. Shrikant Adsul, MD (Gynaec.), 98218 61181, drshrikantadsul@gmail.com
Dr. Shrikant Adsul, MD (Gynaec.)
- Recruiting
Shubham Sudbhawana Superspeciality Hospital,
Varanasi, Uttar Pradesh, 221005
Dr. Pragya Pandey, MBBS MD, 9696519115, pragyamadhukar@gmail.com
Dr. Pragya Pandey, MBBS MD
About this study
Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G. vaginalis and other microbes without affecting lactobacilli. This leads to the treatment of BV while also preventing its recurrence. However, the use of antibiotics may lead to antibiotic resistance and cause various side-effects such as thrush, dizziness, rash, nausea, etc. In the case of many antibiotics, the cure rates were incredibly poor and the BV recurrence rates reached as high as 80 %. Probiotic therapy has slowly been replacing antibiotics for the treatment and prevention of BV and other infections. These probiotics usually contain lactobacilli and help maintain a healthy vaginal environment. They can either be consumed through curd and other milk products that contain probiotics (mostly lactobacilli) or they can be used in the form of suppositories that are placed in the vagina. In probiotics containing lactobacilli, the lactic acid produced by the bacteria lowers the vaginal pH to the ideal range of 3.5 to 4.5 and prevents infection recurrence. Lactobacilli containing suppositories have been successfully used in the past to treat BV, being marketed as a safe and effective way to prevent and treat infections for women in various stages of their lives.
Read the detailed description
The vaginal microbiome is said to be the first line of defence against vaginal infection, due to competitive exclusion and the destruction of pathogenic microbes. The vagina remains relatively sterile until a woman reaches puberty, after which the hormonal changes cause the colonization of lactobacilli in the vaginal environment. Any alterations in the microbiota are seen to cause symptomatic conditions. These conditions may include bacterial vaginosis (BV), vaginal candidiasis and trichomoniasis. The reduction in circulating hormone levels in older women as they near menopause triggers various physiological changes in the vagina. Vulvovaginal atrophy, dryness, itchiness, redness, loss of elasticity, inflammation and atypical secretions are some of the changes that occur in the vagina as estrogen and progesterone levels decrease in the blood.
The aforementioned reduction in hormone levels would also lead to a decline in the concentration of lactobacilli in the vaginal environment. The lactobacilli produce lactic acid, which creates an acidic vaginal environment conducive to the growth of lactobacilli, while preventing the growth of other anaerobic bacterial species. The dominant lactobacilli also prevent the binding of other bacteria to the epithelial cells and the lactic acid produced by lactobacilli blocks histone deacetylases, thereby enhancing gene transcription and DNA repair within their cells. Moreover, the lactobacilli also inhibit the induction of pro-inflammatory cytokines while promoting homeostasis. Some of the species from the Lactobacilli genus that have been identified as residents of the vaginal environment include L. crispatus, L. gasseri, L. iners, and L. jensenii Therefore, it is seen that women who experience lowering of hormone levels i.e. as they approach menopause, the chances of contracting vaginal infection increases due to the lower concentrations of lactobacilli. Bacteria such as Gardnerella, Atopobium, Mobiluncus, Prevotella, Streptococcus, Ureaplasma and Megasphaera, which were previously left dormant due to the lactobacilli, may increase in concentration and increase the susceptibility of these women to contract infections such as bacterial vaginosis.
Bacterial vaginosis is usually caused by the overabundance of G. vaginalis and other anaerobes, and can be clinically diagnosed using the Amsel criteria. This technique requires at least three positive findings of the four diagnostic criteria: a fishy odor after a 10% potassium hydroxide test for vaginal secretion, the presence of non-inflammatory vaginal discharge, clue cells on microscopic examination, and vaginal fluid pH > 4.5. The nugent score is also a well-validated technique to diagnose BV.
In this study, the safety and efficacy of the vaginal suppository VagiBIOM will be studied in aging women with BV infection. The effect of the suppository on vaginal pH and the physiological changes in the vagina will be examined, along with its impact on vaginal infection.
- Conditions
- Bacterial Vaginosis
- Being tested
- Lactobacillus Species, Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus SpeciesDrug
Lactobacilli containing suppositories have been successfully used in the past to maintain the vaginal environment and for treatment of infections like BV. Some of the Lactobacilli species that have been used include Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus plantarum, none of which demonstrated any safety concerns. The investigational product, which contains a Lactobacilli complex as its main component, has already been marketed as a tool to maintain vaginal microbial balance, pH and the prevention of microbial infection, thus there are no additional safety concerns or risks involved in this clinical trial design.
PlaceboOther
Also called Coconut Oil
Coconut Oil Fatty Acids
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus Species Suppositories | Experimental | Coconut oil fatty acids, hyaluronic acid, patented VagiBIOM Probiotic complex CFU (Lactobacillus crispatus Bi16, Lactobacillus gasseri Bi19, Bacillus coagulans Bi34, Lactobacillus acidophilus Bi14) hydrolyzed cellulose, oligofructose, silica gel, lactic acid Receives: Drug: Lactobacillus Species |
| Coconut Oil Suppositories | Placebo comparator | Coconut oil fatty acid suppositories Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of IP on Vaginal pH
To evaluate the efficacy of Investigational product (IP) on Vaginal pH as assessed by a pH indicator from baseline to Day 28 in comparison to placebo.
Measured: Day 0 to Day 28
Secondary outcomes (6)
Evaluate the efficacy of IP on Vaginal pH
Vaginal pH as assessed by a pH indicator from baseline to Day 7 and Day 21 in comparison to placebo.
Measured: Day 7 and Day 21
Evaluate the efficacy of IP on Vaginal Itching
Vaginal itching as assessed by Visual Analogue Scale (0-10) from baseline to Day 28 in comparison to placebo.
Measured: Day 0, Day 7, Day 21 and Day 28
Evaluate the efficacy on Microbial Infection control
Microbial infection control as assessed by the Nugent score from baseline to Day 28 in comparison to placebo.
Measured: Day 0, Day 7, Day 21, and Day 28
Evaluate the efficacy as per Vaginal Health Index
Overall Vaginal Health as assessed through clinical examination using the Vaginal Health Index from baseline to Day 28 in comparison to placebo.
Measured: Day 0 and Day 28
Efficacy as per percentage responders in Nugent Score.
Percentage responders as assessed by the number of BV-free women determined using the Nugent score at Day 28 in comparison to placebo.
Measured: Day 0 and Day 28
To evaluate the total number of Adverse Events
Number of participants who experienced adverse events from baseline in comparison to placebo
Measured: Day 7, Day 21, and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start3 Jan 2022
- Primary completion12 Aug 2022 (estimated)
- Study completion12 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060029
- Sponsor's protocol ID
- BP/210503/VB/VDPH
- Status last verified
- Jan 2022
- First submitted
- 15 Sep 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vivekanandan V, Khan ZH, Venugopal G, Musunuru B, Mishra P, Srivastava S, Ramadass B, Subhadra B. VagiBIOM Lactobacillus suppository improves vaginal health index in perimenopausal women with bacterial vaginosis: a randomized control trial. Sci Rep. 2024 Feb 9;14(1):3317. doi: 10.1038/s41598-024-53770-1.
PubMed 38336815
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH
- ClinicalTrials.gov ID
- NCT05060029
- Acronym / sponsor ID
- BP/210503/VB/VDPH
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 12 Aug 2022 (estimated)
- Study completion
- 12 Aug 2022 (estimated)
- First posted
- 28 Sep 2021 (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.
Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G. vaginalis and other microbes without affecting lactobacilli. This leads to the treatment of BV while also preventing its recurrence. However, the use of antibiotics may lead to antibiotic resistance and cause various side-effects such as thrush, dizziness, rash, nausea, etc. In the case of many antibiotics, the cure rates were incredibly poor and the BV recurrence rates reached as high as 80 %. Probiotic therapy has slowly been replacing antibiotics for the treatment and prevention of BV and other infections. These probiotics usually contain lactobacilli and help maintain a healthy vaginal environment. They can either be consumed through curd and other milk products that contain probiotics (mostly lactobacilli) or they can be used in the form of suppositories that are placed in the vagina. In probiotics containing lactobacilli, the lactic acid produced by the bacteria lowers the vaginal pH to the ideal range of 3.5 to 4.5 and prevents infection recurrence. Lactobacilli containing suppositories have been successfully used in the past to treat BV, being marketed as a safe and effective way to prevent and treat infections for women in various stages of their lives.
Detailed description
The vaginal microbiome is said to be the first line of defence against vaginal infection, due to competitive exclusion and the destruction of pathogenic microbes. The vagina remains relatively sterile until a woman reaches puberty, after which the hormonal changes cause the colonization of lactobacilli in the vaginal environment. Any alterations in the microbiota are seen to cause symptomatic conditions. These conditions may include bacterial vaginosis (BV), vaginal candidiasis and trichomoniasis. The reduction in circulating hormone levels in older women as they near menopause triggers various physiological changes in the vagina. Vulvovaginal atrophy, dryness, itchiness, redness, loss of elasticity, inflammation and atypical secretions are some of the changes that occur in the vagina as estrogen and progesterone levels decrease in the blood.
The aforementioned reduction in hormone levels would also lead to a decline in the concentration of lactobacilli in the vaginal environment. The lactobacilli produce lactic acid, which creates an acidic vaginal environment conducive to the growth of lactobacilli, while preventing the growth of other anaerobic bacterial species. The dominant lactobacilli also prevent the binding of other bacteria to the epithelial cells and the lactic acid produced by lactobacilli blocks histone deacetylases, thereby enhancing gene transcription and DNA repair within their cells. Moreover, the lactobacilli also inhibit the induction of pro-inflammatory cytokines while promoting homeostasis. Some of the species from the Lactobacilli genus that have been identified as residents of the vaginal environment include L. crispatus, L. gasseri, L. iners, and L. jensenii Therefore, it is seen that women who experience lowering of hormone levels i.e. as they approach menopause, the chances of contracting vaginal infection increases due to the lower concentrations of lactobacilli. Bacteria such as Gardnerella, Atopobium, Mobiluncus, Prevotella, Streptococcus, Ureaplasma and Megasphaera, which were previously left dormant due to the lactobacilli, may increase in concentration and increase the susceptibility of these women to contract infections such as bacterial vaginosis.
Bacterial vaginosis is usually caused by the overabundance of G. vaginalis and other anaerobes, and can be clinically diagnosed using the Amsel criteria. This technique requires at least three positive findings of the four diagnostic criteria: a fishy odor after a 10% potassium hydroxide test for vaginal secretion, the presence of non-inflammatory vaginal discharge, clue cells on microscopic examination, and vaginal fluid pH > 4.5. The nugent score is also a well-validated technique to diagnose BV.
In this study, the safety and efficacy of the vaginal suppository VagiBIOM will be studied in aging women with BV infection. The effect of the suppository on vaginal pH and the physiological changes in the vagina will be examined, along with its impact on vaginal infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus Species Suppositories | Experimental | Drug: Lactobacillus SpeciesCoconut oil fatty acids, hyaluronic acid, patented VagiBIOM Probiotic complex CFU (Lactobacillus crispatus Bi16, Lactobacillus gasseri Bi19, Bacillus coagulans Bi34, Lactobacillus acidophilus Bi14) hydrolyzed cellulose, oligofructose, silica gel, lactic acid |
| Coconut Oil Suppositories | Placebo comparator | Other: PlaceboCoconut oil fatty acid suppositories |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Non-pregnant, non-breastfeeding females between the ages of 40 and 65 years, inclusive.
- Participants having at least 3 out of following symptoms or signs:
- Participants with Nugent score of ≥ 7.
- Participants with a total Vaginal Health Index (VHI) score <15.
- Participants with pH ≥ 5.
Key exclusion criteria (22 listed)
- Participants with signs or symptoms of vaginal or cervical or pelvic or 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).
- Participants who are undergoing Hormone Replacement Therapy (HRT).
- Participants on prebiotics or probiotics in the last 1 month.
- Participants who are currently using antibiotics.
- 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.
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 |
|---|---|---|
| Lactobacillus SpeciesLactobacilli containing suppositories have been successfully used in the past to maintain the vaginal environment and for treatment of infections like BV. Some of the Lactobacilli species that have been used include Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus plantarum, none of which demonstrated any safety concerns. The investigational product, which contains a Lactobacilli complex as its main component, has already been marketed as a tool to maintain vaginal microbial balance, pH and the prevention of microbial infection, thus there are no additional safety concerns or risks involved in this clinical trial design. | Drug | Lactobacillus Species Suppositories |
| PlaceboAlso: Coconut OilCoconut Oil Fatty Acids | Other | Coconut Oil Suppositories |
Primary outcome
Evaluate the efficacy of IP on Vaginal pH
Time frame: Day 0 to Day 28
To evaluate the efficacy of Investigational product (IP) on Vaginal pH as assessed by a pH indicator from baseline to Day 28 in comparison to placebo.
6 secondary outcomes
Evaluate the efficacy of IP on Vaginal pH
Time frame: Day 7 and Day 21
Evaluate the efficacy of IP on Vaginal Itching
Time frame: Day 0, Day 7, Day 21 and Day 28
Evaluate the efficacy on Microbial Infection control
Time frame: Day 0, Day 7, Day 21, and Day 28
Evaluate the efficacy as per Vaginal Health Index
Time frame: Day 0 and Day 28
Efficacy as per percentage responders in Nugent Score.
Time frame: Day 0 and Day 28
To evaluate the total number of Adverse Events
Time frame: Day 7, Day 21, and Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 38336815Vivekanandan V, Khan ZH, Venugopal G, Musunuru B, Mishra P, Srivastava S, Ramadass B, Subhadra B. VagiBIOM Lactobacillus suppository improves vaginal health index in perimenopausal women with bacterial vaginosis: a randomized control trial. Sci Rep. 2024 Feb 9;14(1):3317. doi: 10.1038/s41598-024-53770-1.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus Species in people with Bacterial Vaginosis, run by Vedic Lifesciences Pvt. Ltd. at 5 sites 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 13 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shalini Srivastava, MD - Med. (+91-22-42172300, shalini.s@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of IP on Vaginal pH (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060029, which also lists 1 linked publication.
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 2 May 2022.