Evaluation Of Compartive Efficacy Of Marigold ( Tagetes erecta L.) Vaginal Gel Versus Clindamycin Vaginal Gel In Treatment Of Pittaj Yonivyapad (Bacterial Vaginosis)-A Randomized Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the Efficacy Of Marigold (Tagetes erecta L.) Vaginal Gel Versus Clindamycin Vaginal Gel In Treatment Of Pittaj Yonivyapad (Bacterial Vaginosis)
研究概览
简要总结
The volunteer will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC MGACHRC Salod (H) Wardha and CTRI registration will be done. After selection each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a open labelled standard control equivalence clinical trial. It will include a 7 days treatment period and assessment during treatment on 0th 5th 7th day and follow up on 14th day.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients willing to give written consent to participation in research work.
- •Diagnosed patients of pittaj yonivyapad (bacterial vaginosis).
- •Between the age of 18 to 45 years and married irrespective of caste religion and socioeconomic background.
排除标准
- •Pregnancy, PNC mother, menstruating women, menopausal women.
- •Use of antibiotics or antifungal agents in the past 14 days.
- •Known allergy to marigold.
结局指标
主要结局
To assess the Efficacy Of Marigold (Tagetes erecta L.) Vaginal Gel Versus Clindamycin Vaginal Gel In Treatment Of Pittaj Yonivyapad (Bacterial Vaginosis)
时间窗: 0th day 5th day 7th day
次要结局
- To assess the Efficacy Of Marigold (Tagetes erecta L.) Vaginal Gel Versus Clindamycin Vaginal Gel In Treatment Of Pittaj Yonivyapad (Bacterial Vaginosis)(0th day 5th day 7th day)
研究者
DR MITALI DABHADE
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTER SALOD WARDHA