CTRI/2013/01/003288招募中4 期
â??An Active Control, Open label, Randomized, Parallel Group, SingleDose Clinical Study to Evaluate the Therapeutic Equivalence ofClotrimazole 500 mg Vaginal Tablet of Actor Pharma, South AfricaVersus Canesten® (Containing Clotrimazole 500 mg) Vaginal Tablet ofBayer, South Africa in Healthy Adult Females with VulvovaginalCandidiasis.â??
ACTOR PHARMA PTY LTD0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- •Female patients aged between 18 to 45 years.
- •Patient has a primary diagnosis of Vulvovaginal Candidiasis (VVC).
- •Patient willing to give their informed consent.
- •Postmenarcheal females with a diagnosis of VVC will be included based on the criteria listed below.
- •To be clinically evaluable, Patient should have a clinical diagnosis of VVC based on history and physical examination (including vaginal examination). Signs and symptoms to be evaluated include: itching, burning, irritation, edema, erythema and/or excoriation of the vagina/vulva. Each evaluated signs and/or symptoms should be given a numerical rating based on severity
- •Documented Papanicolaou (Pap) test at baseline or during the previous 12 months reported as either â??negative for intraepithelial lesion or malignancyâ?? or â??ASCUS-atypical squamous cells of undetermined significance.â??
- •At baseline, >= 50% of the patient should have at least moderate severity of VVC, defined as having a minimum composite Vulvovaginal signs and symptoms score of 2.
- •Presence of at least one Vulvovaginal symptom (Vulvovaginal itching, burning, or irritation) as assessed by the investigator at baseline.
- •Presence of at least one Vulvovaginal sign (Vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline
- •Clinical diagnosis of symptomatic Vulvovaginal Candidiasis (VVC) confirmed at baseline by positive KOH wet mount test (i.e., when examined microscopically, vaginal secretions obtained by swab of the vaginal mucosa, placed on a slide and diluted with 10% room temperature potassium hydroxide (KOH) reveal filamentous hyphae/ pseudohyphae and/or budding yeast cells).
排除标准
- •Pregnant or nursing women.
- •Patient has Menstruation at the time of diagnosis.
- •Diabetes mellitus [NOTE: If diabetic women are enrolled, it is important that their diabetes be
- •controlled (Fasting blood glucose should be <200 mg/dl) and the proportion of diabetic patient
- •be similar among all treatment groups, because cure rates might differ in diabetic versus non-diabetic women].
- •Insufficiency of liver and/or of kidney (Creatinine > 2.0 mg/dl).
- •Use of systemic, topical (applied to the vulva) or vaginal antibiotics, antifungals or anti-trichomonals within 7 days prior to randomization.
- •Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3
- •months prior to randomization.
- •Presence of concomitant vulvovaginitis caused by other infections (e.g., bacterial vaginosis,
- •Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhoeae).
- •Patient with other infectious causes of vulvovaginitis (e.g., bacterial vaginosis, Trichomonas
- •vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma
- •Sexual intercourse 24 hours before the KOH mount test.
- •Presence of another vaginal or vulvar condition that would confound the interpretation of
- •clinical response.
- •Women who will be under treatment or surgery during the study period for cervical
- •intraepithelial neoplasia (CIN) or cervical carcinoma.
- •History of allergy or sensitivity to clotrimazole, related compounds or any component of the
- •formulation.
- •HSV-IIâ??Tzanck Smear positive patient.
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