ACTRN12620001084976进行中（未招募）2 期
Efficacy of Intravaginal Combination Therapy of Acetic and Lactic Acid (ICTALA) in premenopausal women with Recurrent Vulvovaginal Candidiasis – A Randomised, Double blind Placebo Controlled Clinical Feasibility Trial
Griffith Univeristy0 个研究点目标入组 15 人开始时间: 2020年10月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Female
入选标准
- •1.Premenopausal women
- •2. In good health (no serious current illness or specified chronic diseases, see exclusion criteria)
- •3.A history of RVVC defined as greater than or equal to 4 episodes of Vulvovaginal Candidiasis in a 12 months period as documented in patient medical records and case history, including at least one positive vaginal culture pathology report
- •4. Have a Sobel symptom score <3 at enrolment
- •5. Willing to answer questionnaires and comply with the study requirements.
- •6. Have a menstrual cycle between 26 and 35 days
- •7. Ability to apply intravaginal therapies
- •8. Ability to collect vaginal swabs
- •9. On stable medication(s) and/or Complementary medicines, other than excluded (see below), for greater than or equal to 2 months
排除标准
- •1. Vaginal pH>4.5 at Eligibility screening
- •2. Positive SavvyCheck at Eligibility screening
- •3. Positive Human Chorionic gonadotropin (hCG) urinalysis test at screening (confirming pregnancy), currently pregnant and/or breastfeeding
- •4. Intra uterine device (hormonal or coil, ring pessary)
- •5. Women of child bearing potential who have not been using effective methods of contraception for 14 days prior to Baseline Appointment 1.
- •6. Individuals who are diagnosed with a significant chronic disease, including kidney, liver, uterine and autoimmune disease, sexually transmitted infection (except latent Herpes simplex viruses -HSV1 and HSV2), uncontrolled Diabetes (Type 1 or Type 2, HbA1c >7.5%), vulvar or vaginal medical condition (other than RVVC), pelvic inflammatory disease, recurrent urinary tract infection
- •7. Current cancer or a remission diagnosis in the last 12 months (Skin cancer excision without treatment not a basis for exclusion).
- •8. Individuals taking any medication that addresses hormones including hormone replacement therapy (except the combined OCP), antiestrogens, aromatase inhibitors or any medication of a hormonal blocking nature associated with a breast cancer diagnosis
- •9. Individuals taking HMG-CoA reductase inhibitors, antiretroviral or immunosuppressant medication.
- •10. Individuals taking antifungal, antimicrobial or anti-inflammatory medications applied for a chronic health condition (which can not be ceased)
- •11. Individuals using vaginal douches, taking probiotics (oral or vaginal), or complementary medicines for the management of VVC (Caprylic acid, Origanum vulgare: Oregano herb/oil, Hydrastis canadensis: Golden Seal, Saccharomyces cerevisiae, Handroanthus heptaphyllus:Pau D’arco, Allium sativum: Garlic, Pseudowintera colorata: Horopito) except for those willing and able to cease (if ceased allow a 3 week wash out)
- •12. Individuals who have commenced a new pharmaceutical or complementary medication < 2 months ago (and not willing or able to cease)
- •13. Known allergy to any of the ingredients in the formulation
- •14. Individuals that have participated in another clinical trial in the last 30 days
研究者
相似试验
已完成
2 期
Comparision of clinical efficacy of Intravenous acetaminophen vs ketorolac to relieve pain in renal colicAcute Renal Colic.Urinary calculus, unspecifiedIRCT2015090223855N1Vice- Chancellor for Research, Semnan University of Medical Sciences120
已完成
不适用
The effect of progesterone in Intrauterine inseminatioInfertility.Supervision of high-risk pregnancyIRCT201202078948N1Kerman University of Medical Sciences196
招募中
4 期
Comparison of efficacy and safety of intravenous Alteplase (rt-PA) versus Aspirin therapy to improve outcome in patients with acute ischemic strokeNervous System DiseasesPACTR201905578860441Faculty of medicine80
尚未招募
3 期
Effectiveness of Combined intravenous and Periarticular Tranexamic acid compare to Intravenous Tranexemic acid alone for decreasing blood loss in Simultaneous Bilateral Total Knee Arthroplastyelderly osteoarthritis patientsBilateral total knee arthroplasty , combined periarticular tranexamic acid and intravenous tranexamic, intravenous tranexamicTCTR20221229004Charoenkrung Pracharak Hospital60
已完成
不适用
Comparing three drugs, apotel, oxycodone and acetaminophen codeine analgesia after nasal surgerycontrol of post operative pain.Analgesics, antipyretics and anti-inflammatory drugsIRCT2012062410102N1Vice chancellor for research Tehran University of Medical Science75