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临床试验/CTRI/2018/04/013044
CTRI/2018/04/013044尚未招募2 期

Effect of Palasha Pushpa churna and Palasha seed taila pichu in bacterial vulvovaginitis

Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年5月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Analysis of improvement in sign and symptoms of bacterial vulvovaginitis through various parameters.

研究概览

简要总结

This is an open label, randomised,single center trial evaluating the effect of Ayurvedic formulation Palasha pushpa churna 3gm two times per day with Luke warm water and palasha seed m taila pichu applied locally in management of bacterial vulvovaginitis. Married women of age group 20 to 40 years having sign and symptoms of vaginal discharges,itching in external genitalia, painful urination, vaginal bleeding, pain in vulva and vagina will be selected for study for relieving sign and symptoms.

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
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Married women having sign and symptoms of vulvovaginitis like vaginal discharge (purulent or blood stained), pruritis or soreness in external genitalia, painful urination, vaginal bleeding, pain in vulva and vagina.

排除标准

  • 1.Unmarried patients.
  • 2.Pregnant and lactating mothers.
  • 3.Patients associated with any currently ongoing research study.
  • 4.Psychiatric patients .
  • 5.Patients having any allergy to the drugs.
  • 6.Patients with any specific disease specially of chronic nature such as marked anaemia , T.B., HIV, hypertension, diabetes, hypo/hyper thyroidism, cardiac disese, renal disease, jaundice or any other disorders influencing general physical health .
  • 7.Patient having any organic pathology such as endometriosis, fibroid uterus, carcinoma of uterus and cervix.

结局指标

主要结局

Analysis of improvement in sign and symptoms of bacterial vulvovaginitis through various parameters.

时间窗: first follow up at 7th day,second follow up at 14th day and last follow up at 21th day.

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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