A comparative clinical study to evaluate the effect of madhukadi vati and panchavalkala kwath prakshalana in the management of paripluta yonivyapada with special reference to pelvic inflammatory disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.To evaluate the efficacy of Madhukadi vati and Panchavalkala Kwath prakshalana in the management of Paripluta yonivyapada.
研究概览
简要总结
This is a randomised, comparative clinical study phase 2 parallel group trial. Comparing the efficacy of Madhukadi vati and Panchavalkala kwath Prakshalana in cases of Paripluta Yonivyapad for 2 months in 40 patients. The patient fulfilling the clinical criteria for diagnosis of Paripluta Yonivyapad will be randomly selected from OPD/IPD of State Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into two groups, Group A- In this group patients will be treated with Madhukadi vati orally 2 tabs BD (500mg each) with lukewarm water after meal for the period of 2 months. Group B- In this group patients will be treated with Madhukadi vati orally 2 tabs BD (500mg each) with lukewarm water after meal for the period of 2 months along with Panchavalkala kwath Prakshalana locally in the dose of 500ml for the period of 7 days after cessation of menses.Follow up period every 30 days during the treatment and 30 days after the completion of trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Married women between the age group of 21 to 45 years 2 Patient suffering from abnormal vaginal discharge more than 3 consecutive cycles 3 Cardinal symptoms of Paripluta Yonivyapada Lower abdomen pain Low back pain.
- •Dyspareunia Patient willing for trial.
排除标准
- •1 Pregnant women 2 Unmarried 3 Patient suffering from any systemic disease like tuberculosis hypertension or diabetes 4 Patient having specific pathology of the genital tract ie benign or malignant tumor 5 Severe or chronic ill health conditions 6 Acute PID and peritonitis tubo ovarian abscess.
结局指标
主要结局
1.To evaluate the efficacy of Madhukadi vati and Panchavalkala Kwath prakshalana in the management of Paripluta yonivyapada.
时间窗: after 30 days | after 30 days | after 30 days of trial
2.To compare the efficacy of Madhukadi vati and Madhukadi vati with Panchavalkala Kwath prakshalana in the management of Paripluta yonivyapada.
时间窗: after 30 days | after 30 days | after 30 days of trial
次要结局
- 1.Conceptual study of Paripluta yonivyapada and its modern correlation.(2.To find out the safe and potent drug for Paripluta yonivyapada)