Effect of Rasaut in Bacterial vaginosis – A pre and post analysis study
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
Dr Najma Fathima
Government Unani Medical College and Hospital
