Comparative Clinical Study of Unani Formulations in the Management of Bacterial Vaginosis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Clinical cure defined as resolution of subjective symptoms of vaginal discharge
研究概览
简要总结
Patients meeting all the inclusion criteria will be randomly allocated to either of the three test groups (n=25 in each groups) after taking their consent. In one group, Mochras Firzaja per vaginum will be given daily at bedtime. In second group, Ma‘jūn Mochras 10gm will be given orally with water for duration of 3 weeks. In third group, Ma‘jūn Mochras 10gm orally with water will be given in the morning daily along with Mochras Firzaja per vaginum daily at bedtime for the duration of 3 weeks. . Follow up will be done on weekly basis during the treatment and post treatment follow ups fortnightly will be done after completion of the treatment. Subjective parameters will be assessed on each visit while objective parameters will be assessed before and after completion of the treatment.
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
- •Married women above the age of 18 years with regular menstrual cycle Complain of vaginal discharge associated with low backache lower abdominal pain and vulvae itching ï‚· Positive Amsel’s criteria.
排除标准
- •Pregnant, lactating and menopausal women Women on antibiotics and hormones in present and recent past Women with IUCDs Women with other pelvic pathology STDs genital prolapse and unhealthy cervix Women with known history of systemic and endocrinal diseases.
结局指标
主要结局
Clinical cure defined as resolution of subjective symptoms of vaginal discharge
时间窗: Baseline | 1st Week | 2nd Week | 3rd Week
backache lower abdominal pain and vulval itching assessed by VAS
时间窗: Baseline | 1st Week | 2nd Week | 3rd Week
次要结局
- Negative Whiff test Normalization of vaginal pH Negative saline mount and(decreased Clue cells)
研究者
Rushda Fatma
State Takmeel Uttib College and Hospital Lucknow