CTRI/2024/05/068227已完成3 期
A Randomized, Open label, Comparative clinical study to compare and evaluate Efficacy and Safety of the Candimilt 500 soft gelatin vaginal capsules containing Clotrimazole 500 mg and the Candid V3 vaginal tablets containing Clotrimazole 200 mg in patients with Vulvovaginal Candidiasis
Miltonia Health Science Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for candidal vaginitis
研究概览
简要总结
Adult human females (non-pregnant & non-lactating) with the age limit of greater than or equal to 18 years, diagnosed to be suffering from vulvovaginal candidiasis will be included in the present study and efficacy and safety of the Candimilt 500 vaginal capsules containing Clotrimazole 500 mg produced for Miltonia Health Science Ltd, United Kingdom will be evaluated in comparison with Candid V3 vaginal tablets containing Clotrimazole 200 mg
Primary Outcome
- Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for candidal vaginitis 2) Clinical Response (Time frame : at 7th and 14th after start of treatment) 3) Number of patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline 4) Improvement or resolution of local signs of inflammation 5) A vulvovaginal symptoms questionnaire (VSQ) will be done at baseline and end of study 6) Changes from baseline to 4- weeks in Quality of Life Questionnaires 7) Photographic assessment of improvement and test product dissolution status 8) Microbiological cure - evaluation : microscopy of vaginal discharge smears will be done on baseline and on day 7 and 14
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with the symptoms of vulvovaginal candidiasis (based on symptoms and signs after speculum examination);
- •Non-pregnant female patients aged 18 years and above and clinically diagnosed with vulvovaginal candidiasis were included;
- •Capable of giving written informed consent and willing to follow the investigational study procedures and report AEs.
- •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);
- •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);
- •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;
- •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;
- •Patients must abstain from alcohol ingestion during the treatment period and for one day afterward.
排除标准
- •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.
结局指标
主要结局
1) Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for candidal vaginitis
时间窗: DAy 7, 14 and 28
2) Clinical Response
时间窗: DAy 7, 14 and 28
3) Number of patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline
时间窗: DAy 7, 14 and 28
4) Improvement or resolution of local signs of inflammation
时间窗: DAy 7, 14 and 28
5) A vulvovaginal symptoms questionnaire (VSQ) will be done at baseline and end of study
时间窗: DAy 7, 14 and 28
6) Changes from baseline to 4- weeks in Quality of Life Questionnaires
时间窗: DAy 7, 14 and 28
7) Photographic assessment of improvement and test product dissolution status
时间窗: DAy 7, 14 and 28
8) Microbiological cure - evaluation : microscopy of vaginal discharge smears will be done on baseline and on day 7 and 14
时间窗: DAy 7, 14 and 28
次要结局
- 1. The secondary endpoint of the study is to assess the safety of subjects enrolled in the intent-to- treat (ITT) population who achieve therapeutic cure by monitoring Adverse drug reactions and laboratory abnormalities if any from baseline to post study on day 28.
研究者
Dr Uthpala Vadakaluru
Mahatma Gandhi Medical College
研究点 (1)
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