CTRI/2023/05/052560
Active, not recruiting
未知
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of LactoSpore® as an adjuvant in the treatment of Bacterial Vaginosis
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sami Sabinsa Group Limited
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female patients with reproductive potential aged more than 18 years to less than 45years.
- •2\. Patients with signs \& symptoms of Bacterial Vaginosis confirmed by Amsel Score \>3\.
- •a) Thin, homogenous, or milky vaginal discharge
- •b) Vaginal pH greater than 4\.5 (i.e., greater than normal)
- •c) Positive whiff test (fishy amine odor when 10 percent potassium hydroxide solution is added)
- •d) Presence of \> 20% per HPF of Clue cells on wet mount examination.
- •3\. Confirmed case of BV with a Nugent Score above 3\.
- •4\. Participants with FBS \<110 mg/dL under no medication.
- •5\. Participants with FBS \< 140mg/dL with medication but not on Insulin.
- •6\. Participants with HbA1c \< 6\.5\.
Exclusion Criteria
- •1\. Possible allergic symptoms related to the study’s test supplements.
- •2\. Women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.
- •3\. Participants who are in menopausal transition / menopause.
- •4\. Less than 6 weeks since the last delivery or abortion.
- •5\. Mixed vaginal infection including bacterial vaginosis and trichomoniasis or coexistent infections with genital herpes and cervicitis.
- •6\. Participants who are using vaginal medication, vaginal contraceptives or douches within 48 hours prior to the test.
- •7\. Participants who are having sexual intercourse within 24 hours prior to the test.
- •8\. Patients having sexually transmitted diseases and unhealthy cervix.
- •9\. Participants with history of PCOD and Hysterectomy.
- •10\. Individuals on special diet, gastric diseases, those taking additional vitamins, minerals, supplements \& new contraceptive pills.
Outcomes
Primary Outcomes
Not specified
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