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临床试验/CTRI/2023/11/060358
CTRI/2023/11/060358尚未招募2 期

Clinical Study of Bacterial Vaginosis(Jarasime Iltehabe Mehbal)and its Management with Gule Dhawa(Woodfordia Fruticosa)

Pg Department of Obstetrics and Gynaecology(Ilmul Qabalath wa Amraz e Niswan)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月8日最近更新:

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
Vaginal swab culture

研究概览

简要总结

Bacterial vaginosis (BV) is a condition characterized by raised vaginal PH & MILKY white discharge in which the normal vaginal flora is replaced by mixed flora of aerobic anaerobic & microaerophilic species.

 Bacterial Vaginosis is one of the common causes of vaginal discharge in the reproductive age group.

 Non-specific vaginitis (NSV) also named bacterial vaginosis.

 Bacterial vaginosis is termed vaginosis rather than vaginitis. It is associated with alternation in the normal vaginal flora rather than due to any infection. There is a considerable decrease in the number of lactobacilli in the vaginal discharge with 100 folds increase in the growth of other anaerobic Bacteria since lactobacilli release hydrogen peroxide toxic to other bacteria reduction in their number to allow other bacteria ie. aerobic & anaerobic bacteria to grow Therefore bacterial vaginosis is a polymicrobial condition.

 The vagina is a fibromuscular membraneous sheath communicating the uterine cavity with the exterior at the vulva. it constitutes the excretory channel for the uterine secretion & menstrual blo od.

 To evaluate the efficacy of Unani drugs in the cases of bacterial vaginosis

 To determine the safe, easily available and cost-effective Unani drugs used in bacterial vaginosis.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Married patients between the age group 18 to 45 years 2.Complaining of vaginal discharge 3.Already diagnosed cases.

排除标准

  • 1.Patients presenting with blood-stained discharge 2.Pregnant lactating women 3.Trichomonas vaginitis candidiasis vaginitis 4.Patient with any organs pelvic pathology 5.Patient with systemic illness malignancy 6.Patients with AIDS, syphilis, Gonorrhoea 7.Patient with HTN, DM.

结局指标

主要结局

Vaginal swab culture

时间窗: Each Patient Outcome Depends on After 2 Cycles of Successful Oral Medicine ie 60days And Vaginal Suppository(HUMMOUL)Each Month 10 days

次要结局

  • Changes in Amsels criteria(Each Patient Outcome Depends on After 2 Cycles of Successful Oral Medicine ie 60days And Vaginal Suppository(HUMMOUL)Each Month 10 days)

研究者

发起方
Pg Department of Obstetrics and Gynaecology(Ilmul Qabalath wa Amraz e Niswan)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rayees Unnisa

Government Nizamia Tibbi College and General Hospital

研究点 (1)

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