Health Condition 1: N761- Subacute and chronic vaginitis
Conditions
Interventions
Intervention1: Lactobacillus helveticus: Two capsules to be taken orally once daily after breakfast for 2 weeks.
Control Intervention1: Placebo: Two capsules to be taken orally once daily after breakf
Sponsors
NEWTREE Co. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult female subjects. 2. Night score of 4-6. 3. Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 4. Patient should be able to give written informed consent prior to participating in the study.
Exclusion criteria
Exclusion criteria: 1.Individuals currently undergoing treatment for vaginal or urinary tract infections. 2.Individuals with vaginal bleeding, abnormal vaginal discharge, or genitourinary abnormalities. 3.Individuals who have been administered antibiotics, antifungals, steroids, or immunosuppressants within 2 weeks prior to screening. 4.Individuals who have received feminine hygiene products, vaginal douches, mug wort fumigation, or acupuncture treatment for vaginal health within 2 weeks prior to screening. 5.Individuals with diseases such as uterine cancer, ovarian cancer, uterine fibroids, ovarian cysts, endometrial polyps, candidal vaginitis, or trichomonal vaginitis that require treatment based on vaginal ultrasound and internal examination results (to be excluded at the discretion of the principal investigator). 6.Individuals with clinically significant acute or chronic cardiovascular, cerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory, hematologic and oncologic diseases, or gastrointestinal diseases requiring treatment. 7. Patients with uncontrolled hypertension. 8.Patients with uncontrolled diabetes mellitus 9. Individuals with TSH below 0.1muU/mL or above 10muU/mL. 10.Individuals with a BMI of less than 18.5 kg/m2 or greater than 35 kg/m2 at the time of screening. 11.Individuals who have consumed health functional foods for improving vaginal health, probiotics, and products containing lactic acid bacteria continuously (4 times or more per week) within 1 month prior to screening (refer to prohibited concomitant medications). 12.Individuals with a history of receiving antipsychotic medication treatment within 3 months prior to screening. 13.Individuals with or suspected of having alcohol dependence or drug abuse . 14.Individuals with a history of significant hypersensitivity reactions to the ingredients. 15.Individuals who have participated in other clinical trials within 3 months prior to screening. 16.Individuals who exhibit the following results in diagnostic medical examinations AST,ALT more than 3 times the upper limit of the normal range Serum Creatinine more than 2.0 mg/dL. 17.Pregnancy and breastfeeding women 18.Individuals who do not agree to use appropriate contraceptive methods 19.Participation in concomitant interventional clinical study or during the previous 30 days 20.Individuals deemed ineligible for research participation by the principal investigator due to diagnostic medical examination results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Increase in beneficial bacteria in the vagina and decrease in harmful bacteria in the vagina.Timepoint: Baseline week 2 and 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Decrease in Nugent score. 2 Improvement in vaginal pH. 3 Change in VAS for vaginal symptoms 4 Increase of beneficial bacteria & decrease in anaerobic bacteria in the faecal matter. 5 Detection of Lactobacillus helveticus ES1205 in vagina. 6 Detection of Lactobacillus helveticus ES1205 in faecal matter. 7 Compliance & tolerability. 8 Safety will be assessed throughout by AE reporting, laboratory testing by doing hematology & biochemistry & UPT test, physical examination, any adverse effects & vital signs. 9 Compliance & tolerability.Timepoint: Screening baseline week 2 & 6 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd.
Outcome results
None listed