CTRI/2023/05/052560进行中（未招募）Unknown
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
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
- •7. Ability to swallow and retain oral medications as per the protocol.
- •8. Participants should be willing to give written informed consent.
- •9. Participants should be willing to comply with requirements of the trial/ study.
排除标准
- •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.
- •11. Recent use of any systemic or local antibiotics or probiotics in the past one month.
- •12. Patients with a diagnostic history of clinically significant thyroid disorder (hypo or hyper), cardiovascular (congenital heart disease, cardiomyopathy, heart failure, valvular heart disease) hematological, hepatic, renal, respiratory, malignancy or genitourinary abnormalities or diseases or systemic diseases like hypertension, diabetes, or any clinical condition, according to the investigator which does not allow safe fulfilment of the study protocol.
- •13. History of chronic smoking and Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
- •14. Those who have participated in another clinical trial within the past 1 month of screening visit (visit 1) or those who plan to participate in any other study during the clinical trial period.
- •15. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion.
- •16. Any planned surgery during the study period.
- •17. Any other reason(s) as per principal investigator discretion.
研究者
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