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临床试验/CTRI/2016/02/006606
CTRI/2016/02/006606已完成3 期

A randomized clinical trial of swetapradara w.s.r. to infective vaginal discharge with Nimbadi yonivarti and Vidangadi lauha

INSTITUTE FOR POST GRADUATE TRAINING AND RESEARCH IN AYURVEDA1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年2月20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
300
试验地点
1
主要终点
To evaluate and compare the effect of Nimbadi Yonivarti and Nimbadi Yonivarti with Vidangadi lauha orally in the management of Swetapradara w.s.r. infective vaginal discharge

研究概览

简要总结

This study is on infective vaginal discharge. Drugs used for this study are Nimbadi Yonivarti and Vidangadi lauha Tablet. In Group A, Nimbadi Yonivarti is given once a day per vaginally at bed time for 15 days. In Group B, NImbadi Yonivarti is given once a day per vaginally at bed time and two  tablet (500mg each)  of  Vidangadi lauha are given orally  two times a day after meal for 15 days.Followup is taken for 1 month with the interval of 15 days. Before and after treatment , wet vaginal study, gram stain,10% KOH preparation, Vaginal discharge for culture(Aerobic and fungal) and vaginal pH are done in each patients for assesment of result

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Married women.
  • The patients having clinical signs and symptoms of Swetapradara i.e. features of white discharge with itching / any abnormal smell/swelling ,redness.
  • Detection of pathogen by wet vaginal smear examination including any featrures either one/ two/three/all.
  • Hemoglobin greater than 7gms%.

排除标准

  • Unmarried women Age below 20 years and above 50 years pregnant women patients suffering from tuberculosis, HIV, VDRL, Genital malignancy and Congenital and any other organic pathologies of reproductive tract Hemoglobin less than 7.

结局指标

主要结局

To evaluate and compare the effect of Nimbadi Yonivarti and Nimbadi Yonivarti with Vidangadi lauha orally in the management of Swetapradara w.s.r. infective vaginal discharge

时间窗: 16 days

次要结局

  • To prevent recurrence rate of infective vaginal discharge(45 days)

研究者

发起方
INSTITUTE FOR POST GRADUATE TRAINING AND RESEARCH IN AYURVEDA
申办方类型
Research institution and hospital

研究点 (1)

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