An Open label Clinical study to evaluate the efficacy and safety of B C CAPS manufactured by NUTRA GRACE in Abnormal vaginal discharge due to microbial infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NUTRA GRACE
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in microbiological parameters
研究概览
简要总结
There are various synthetic antifungal medications and vaginal suppositories which are approved worldwide for the treatment of vaginal infections. The present composition of herbal drug B C CAPS is a formulation of neem seed oil having anti fungal, anti bacterial activity and anti viral which offers potential for therapeutic and prophylactic use at global level, especially in epidemics. Each of these properties offers specific healing components including inhibiting viruses and fungi, destroying bacteria, relieving pain, reducing inflammation and tenderness and eradicating other microorganisms. B C CAPS is a blended formulation of Neem seed oil which is very well known for their properties as an antimicrobial agent. Indicated for Genital Candidiasis, Chronic candida infection and bacterial vaginosis. There are no contra-indications or health risks associated with B C Capsules. 2 capsules to be administered manually in vagina before going to bed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age 18- 45 yrs
- •Subjects with presence of signs and symptoms such as irritation, soreness, dysuria, vulvovaginal inflammation (edema, erythema) and abdominal pain.
- •Subjects with confirmed laboratory diagnosis of abnormal vaginal discharge.
- •Subjects willing to give written informed consent and come for a regular follow up.
排除标准
- •Allergy to neem products.
- •Pregnant subjects.
- •Patients who had taken oral or intravenous antifungal agents within 4weeks or used topical vaginal antifungal drugs within 1 week before enrollment.
- •Terminally ill patients or patients with severe cardiac, hepatic renal or cerebrovascular disease, malignancy, chronic uncon-trolled systemic disease e.g. hypertension, collagen disorders, etc or any other serious medical illness.
- •Patients who have participated in a new drug study in the past 3 months.
- •Any other condition that in the opinion of the investigator does not justify the patient’s participation in the study.
结局指标
主要结局
Change in microbiological parameters
时间窗: Baseline and Day 14
次要结局
- Change in Subjective assessment of symptoms(Baseline and Day 1 to 14)
- Continuous monitoring for AEs and SAEs(Day 1 to 14)
- Change in Clinician’s assessment of symptoms(Baseline, Day 7 and Day 14)