CTRI/2024/05/068227尚未招募3 期
A Randomized, Open label, Comparative clinical study to compare and evaluateEfficacy and Safety of the Candimilt 500 soft gelatin vaginal capsulescontaining Clotrimazole 500 mg and the Candid V3 vaginal tablets containingClotrimazole 200 mg in patients with Vulvovaginal Candidiasis - NI
Miltonia Health Science Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
- •Women with the symptoms of vulvovaginal candidiasis (based on
- •symptoms and signs after speculum examination);
- •1. Non-pregnant female patients aged 18 years and above and clinically
- •diagnosed with vulvovaginal candidiasis were included;
- •2. Capable of giving written informed consent and willing to follow the
- •investigational study procedures and report AEs.
- •3. Subjects must not be on their menstrual period on the day of screening
- •and do not anticipate their period to begin during treatment (3 days);
- •4. Subjects must be using an acceptable method of birth control, willing
- •to refrain from sexual intercourse from the date of screening until the
- •follow-up visit (approximately 7 days later);
- •5. Willing to refrain from the use of any intravaginal/ vulvovaginal
- •products (douches, spermicidal foams or gels, vaginal lubricants, etc)
- •from the screening visit until the follow up visit;
- •6. Patients who have complaint of abnormal vaginal odour with or
- •without complaints of discharge and those were not treated for
- •bacterial vaginosis, intra-vaginal or oral anti-fungal medications or
- •antibiotics, within the last 14 days of enrolment;
- •7. Patients must abstain from alcohol ingestion during the treatment
- •period and for one day afterward
排除标准
- •1)usage of any topical or systemic medication, particularly antimicrobial agents over a 30-day period prior to the start of the investigation
- •2)positive pregnancy test at screening
- •3)Previously diagnosed with (HIV) infection, having visible vaginal or cervical mass suspected cancer, and within six weeks of post-abortion or postpartum
- •4)Women who are currently or who will require treatment with anticoagulants, lithium, disulfiram, or neuromuscular blocking agents
- •5)breastfeeding
- •6)Study will also exclude patients with history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition7)Patients with a history of seizure disorders
- •8)Patients with renal impairment 9) Patients with hepatic impairment10)History of uncontrolled Diabetes Mellitus and hypertension
- •11)Inability to comply with the protocol requirements
- •12)Participation in any other clinical trial within 3 months of registering in this trial
- •13)Patients receiving diuretics or related medicines;14)Post-menopausal women/Menstruating at the time of diagnosis; 15)Use of oral or intravaginal antibiotics within the past 2 weeks;
- •16)Immunosuppressive drug within 4 months
- •17)Presence of vaginal / vulval ulcer any other vulval, vaginal or medical condition, including cervicalneoplasia/ treatment that might confound treatment response
- •18)Inability to keep return appointments19)History of hypersensitivity to clotrimazole, clindamycin or lincomycin or any excipient in the drug formulation regional enteritis, ulcerative colitis or ‘antibiotic associated’ colitis 20)Intrauterine device
研究者
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