CTRI/2022/01/039560已完成未知
A Pilot Study to Evaluate the Efficacy and Safety of VagiBIOM Suppositories on Vaginal Health and pH.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 69
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. Non-pregnant, non-breastfeeding females between the ages of 40 and 65 years, inclusive.
- •2. Participants having at least 3 out of following symptoms or signs:
- •2.1 Homogeneous, thin, white discharge that smoothly coats the vaginal walls;
- •2.2 Presence of the clue cells on microscopic examination (as assessed by wet mount test)
- •2.3 pH of vaginal fluid ââ?°Â¥5
- •2.4 A fishy odor of vaginal discharge.
- •3. Participants with Nugent score of ââ?°Â¥ 7.
- •4. Participants with a total Vaginal Health Index (VHI) score <15.
- •5. Participants with pH ââ?°Â¥ 5.
- •6. Willing to abstain from sexual intercourse 48 hours prior to scheduled clinic visit.
- •7. Participants able to comply with and perform the procedures requested by the protocol (including IP compliance, blood sample collection procedures and study visit schedule).
- •8. Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
- •9. Participants able to give written informed consent and willingness to participate in the study and comply with its procedures.
排除标准
- •1. Participants with signs or symptoms of vaginal/cervical/pelvic/ 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).
- •2. Participants who are undergoing Hormone Replacement Therapy (HRT).
- •3. Participants on prebiotics or probiotics in the last 1 month.
- •4. Participants who are currently using antibiotics.
- •5. 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.
- •6. Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system.
- •7. Participants who have been diagnosed with polycystic ovary syndrome (PCOS).
- •8. Uncontrolled type II diabetes mellitus (assessed by RBS ââ?°Â¥140 mg/dL.)
- •9. Use of an immunosuppressive or immunomodulatory drug within 6 months prior to enrolment.
- •10. Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) ââ?°Â¥ 140 mm Hg and/or diastolic blood pressure (DBP) ââ?°Â¥ 90 mm Hg).
- •11. Abnormal Thyroid Stimulating Hormone (TSH) value out of reference range of 0.35 to 5.00 Ã?¼IU/mL.
- •12. History of any significant neurological and psychiatric condition which may affect the participation and inference of the studyââ?¬•s end points.
- •13. Participation in other clinical trials in last 3 months prior to screening.
- •14. Smokers (Past smokers can be allowed if they have abstinence for minimum 2 years).
- •15. Chronic or sporadic abdominal pain including moderate to severe dysmenorrhoea.
- •16. Substance abuse problems (within 2 years) defined as:
- •16.1 Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- •16.2 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.
- •17. 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.
- •18. History of hepatitis B/ hepatitis C/ HIV infection.
- •19. Regular medical treatment including OTC, which may have impact on the study aims (e.g., probiotics, antibiotic drugs, laxatives etc.)
- •20. Any condition that could, in the opinion of the investigator, preclude the participantââ?¬•s ability to successfully and safely complete the study or that may confound study outcomes.
研究者
相似试验
尚未招募
不适用
A Pilot study to Evaluate the Efficacy and Safety of Autologous Adipose tissue-derived Stromal Vascular Fraction(SVF) treatment for the Patients with articular cartilage injury of the kneeKCT0005566Samsung Medical Center3
进行中（未招募）
1 期
A Pilot study to evaluate the Efficacy and Safety of GFT505 orally administered once daily (30 mg) for 28 days in atherogenic dyslipidaemic patients with abdominal obesity. A double blind, placebo-controlled and randomized study.EUCTR2007-004337-41-FRGENFIT30
进行中（未招募）
1 期
A Pilot study to evaluate the Efficacy and Safety of GFT505 (80mg) orally administered once daily for 35 days in patients presenting with impaired glucose tolerance and abdominal obesity. A double blind, parallel group, placebo-controlled and randomized study.patients presenting with impaired glucose tolerance and abdominal obesityMedDRA version: 9.1Level: LLTClassification code 10036481Term: Pre-diabetesMedDRA version: 9.1Level: LLTClassification code 10059179Term: Abdominal obesityEUCTR2009-011003-23-FRGENFIT40
进行中（未招募）
1 期
A Pilot study to evaluate the Efficacy and Safety of GFT505 (80 mg) orally administered once daily for 28 days in atherogenic dyslipidaemic patients with abdominal obesity. A double blind, placebo-controlled and randomized study.Atherogenic dyslipidaemic patients with abdominal obesityMedDRA version: 9.1Level: LLTClassification code 10058108Term: DyslipidaemiaMedDRA version: 9.1Level: LLTClassification code 10059179Term: Abdominal obesityEUCTR2008-005779-86-FRGENFIT90
进行中（未招募）
1 期
A Pilot study to evaluate the Efficacy and Safety of GFT505 (30 mg) orally administered for 28 days in patients with Frederickson Type IIb Dyslipidemia (Mixed Hyperlipidemia). A double blind, placebo-controlled and randomized study.EUCTR2007-003237-16-FRGENFIT30