跳至主要内容
临床试验/CTRI/2024/01/061204
CTRI/2024/01/061204尚未招募2 期

Effect of Rasaut in Bacterial vaginosis – A pre and post analysis study

Government Unani Medical College & Hospital Bangalore-5600791 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年1月16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
35
试验地点
1
主要终点
Improvement in Amsel criteria

研究概览

简要总结

Bacterial vaginosis (BV) is a polymicrobial syndrome having
alteration in the vaginal flora involving a decrease in Lactobacilli and
predominance of anaerobic bacteria such as Gardnerella vaginalis, Mobiluncus
species, Prevotella species, Mycoplasma hominis and Atopobium vaginae. BV
is the most common cause vaginal discharge in the reproductive aged women. Of
symptoms, a non-irritating, offensive fishy odor, homogenous white,
non-viscous vaginal discharge is characteristic.  But it may not
always be present as at least 50% of the patients are asymptomatic.The
prevalence of BV differs widely from country to country within the same
region and even within similar population groups, it has been estimated to be
in the range of 8% to 75%.Maximum incidence of vaginal discharge
seen was in the age group of 20-29 years. BV was found
significantly more in married females as compared to unmarried, and in women with sexual transmitted infections (STIs), who have recently
changed their sex partner, multiple sexual partner, cigarette smoking,
stress, low socioeconomic status (SES), use of intra uterine device (IUCD),
frequent vaginal douches, early age at first intercourse and black ethnicity. Women with BV have increased risk of pelvic inflammatory disease (PID),
leading to infertility and abortions.

In conventional method, the first choice to treat reproductive tract infections according to different pathogens is antibiotics. Most of the drugs used are Metronidazole, Clotrimazole pessary and other antibiotics like doxycycline and Ciprofloxacin which causes side effects and which are effective temporarily, but the problem tends to recur once the medication is stopped.Further, antimicrobial resistance is increased rendering some regimen ineffective and the new agents are expensive. Thus, there is a need of new formulations with fewer side effects.

In Unani concept and view the symptoms of BV is similar to that of Saylan-al-Rahim and many drugs are available to treat Saylan-al-Rahim in Unani system of Medicine. After reviewing the literature, it has been decided to conduct a clinical study of Rasaut (Berberis aristata) on scientific parameters in patients with bacterial vaginosis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Married women between 18-45 years of age with complaints of vaginal discharge associated with low backache and positive Amsel criteria.

排除标准

  • Patients suffering from malignancies and STDs History of recent antibiotic therapy.
  • Patients using OCPs and IUCDs. Pregnant & lactating women.
  • Trichomoniasis, candidiasis, gonorrhoea and other types of vaginitis.

结局指标

主要结局

Improvement in Amsel criteria

时间窗: Patients will be followed on 0 day, 7th day and 14th day

次要结局

  • Improvement in SF – 12 scale for QoL(Patients will be followed on 0 day, 7th day and 14th day)

研究者

发起方
Government Unani Medical College & Hospital Bangalore-560079
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Najma Fathima

Government Unani Medical College and Hospital

研究点 (1)

Loading locations...

相似试验