CTRI/2023/02/049628尚未招募3 期
A randomized, double blind, comparative clinical study to compare and evaluate Efficacy and Safety of the Candimilt® 500 vaginal capsules (Miltonia Health Science Ltd) containing Clotrimazole 500 mg and the original drug Canesten® vaginal tablets containing Clotrimazole 500 mg, Bayer AG, Germany in patients with vulvovaginal candidiasis
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
- •1. Women with the symptoms of vulvovaginal candidiasis (based on symptoms and signs after speculum examination);
- •2. Age at least 18 years;
- •3. Capable of giving written informed consent;
- •4. Agree to no intercourse for 8 days from the day of beginning of treatment;
- •5. Agree not to douche or use any intra-vaginal products during the study period (including tampons, medications and devices);
- •6. Non-pregnant Female patients aged 18 years or more and clinically diagnosed with vulvovaginal candidiasis were included;
- •7. Capable of giving written informed consent and willing to follow the investigational study procedures and report AEs.
- •8. 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);
- •9. 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);
- •10. 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;
排除标准
- •1. Women will be excluded from the study if they are using or has used any topical or systemic medication, particularly antimicrobial agents over a 30-day period prior to the start of the investigation;
- •2. Female patient has a positive pregnancy test at screening, is pregnant or lactating, or is planning to become pregnant during the study period;
- •3. Previously diagnosed with human immunodeficiency virus (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. Women are hypersensitive to clindamycin, clotrimazole or to any excipient in the drug formulation;
- •6. Female patients who are breastfeeding or intending to breast feed during study period;
- •7. 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 condition;
- •8. Patients with a history of seizure disorders;
- •9. Patients with renal impairment (S. Creatinine > 1.5 times the normal reference values)
- •10. Patients with hepatic impairment. [SGOT, SGPT, S. Bilirubin (Total) >1.5 times the normal reference values;
- •11. History of uncontrolled Diabetes Mellitus;
- •12. Patients with uncontrolled hypertension;
- •13. Inability to comply with the protocol requirements;
- •14. Participation in any other clinical trial within 3 months of registering in this trial;
- •15. Patients receiving diuretics or related medicines;
- •16. Post-menopausal women;
- •17. Menstruating at the time of diagnosis;
研究者
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