跳至主要内容
临床试验/CTRI/2015/05/005747
CTRI/2015/05/005747已完成1 期

“A CLINICAL STUDY ON UPAPLUTA YONIVYAPAD w.s.r. TO VULVOVAGINITIS DURING PREGNANCY & ITS MANAGEMENT WITH DHATAKYADI VARTIâ€

IPGTRA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年11月1日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
PATIENT GOT SYMPTOMATIC RELIVE IN BOTH GROUPS

研究概览

简要总结

VULVOVAGINITIS IS THE PROBLEM OF PREGNANT WOMEN THAT CHALLENGES THE  OBSTETRICIAN TODAY.ANY INFECTION OF BIRTH CANAL MAY LEAD PREMATURE RUPTURE OF MEMBRANE,PRE TERM DELIVERY ETC.TREATMENT MODALITY  IN ALLOPATHIC MEDICINE INCLUDES ANTI FUNGAL,ANTI BACTERIAL DRUGS .BUT ALL  HAVE UNSATISFACTORY RESULTS AND THEY ALSO HAVE SOME SIDE EFFECTS LIKE LOCAL BURNING SENSATION ,HYPER SENSITIVITY ETC.SO,THERE IS A GREAT SCOPE OF RESEARCH TO FIND OUT SAFE,POTENT,EFFECTIVE AND LESS COSTLY REMEDY OF AAYURVEDA FOR MANAGEMENT OF VULVOVAGINITIS DURING PREGNANCY.VARTI KALPANA IS CONVENIENT FOR PATIENT TO ADMINISTER BY OWN SELF AND NO NEED OF ANY PRECAUTION SO VARTI KAlPANA WAS SELECTED FOR STUDY

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
19.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.The pregnant women with different parity having signs and symptoms of vulvovaginitis.
  • 2.Age 19 to 40years.
  • 3.White discharge present during examination.
  • 4.Inflammation present in vulva and vagina.
  • 5.Pathogens present in wet slide study and vaginal swab culture.

排除标准

  • 1.Non pregnant Women.
  • 2.Age below 19yrs or above 40 yrs 3.Hypersensitivity to drug and inability to conform the protocol.
  • 4.Women with severe Physical illness, any systemic disease like D.M.,any organic Pathology, Hepatic, Cardiac, Renal disease and any acute Infection of any system, 5.Women suffering from disease like S.T.D.,H.I.V.etc.

结局指标

主要结局

PATIENT GOT SYMPTOMATIC RELIVE IN BOTH GROUPS

时间窗: AFTER 14 DAYS OF TREATMENT

次要结局

  • TO PREVENT COMPLICATION LIKE PRE MATURE RUPTURE OF MEMBRANE AND PRE TERM LABOR(TO PREVENT COMPLICATION LIKE PRE MATURE RUPTURE OF MEMBRANE AND PRE TERM LABOR)

研究者

发起方
IPGTRA
申办方类型
Research institution and hospital

研究点 (1)

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