Assessment of pre and post therapeutic outcome of reproductive age group women suffering from bacterial vaginosis by individualized homoeopathic medicine comparing its effect through in- vitro analysis
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
- Assessment of change in the symptoms will be recorded on the basis of score either increase or decrease obtained by VSQ21 and Hay’s classification system with Nugent scoring.
研究概览
简要总结
Bacterial vaginosis is a commonly occurring vaginal infection that leads to an abnormal vaginal discharge and unpleasant odour. conventional, widely-utilized approach for diagnosing bacterial vaginosis relies on Amsel’s Criteria (~90% sensitivity and specificity): 1. White, milky, no viscous discharge adherent to the vaginal wall 2. pH of the discharge is more than 4.5 3. The presence of clue cells (vaginal epithelial cells with adherent Gardnerella on high-power microscopic examination after adding a drop of normal saline to a vaginal fluid smear (wet mount), and 4.A positive “whiff test†upon application of a few drops of 10% potassium hydroxide (alkaline solution) to a sample of vaginal fluid. after patient’s consent, clinically per speculum examination will be done without any lubricant to see the colour, odour of the discharge, to evaluate the Amsel’s criteria. Discharge collected twice with sterile vaginal swab collection kit one for the whiff test and other for the culture in agar plate. Instantly pH will be determined with pH strip. Analysis and evaluation of the symptoms will be done as per guidelines of homoeopathic philosophy and further constructing the totality in accordance to it. Repertorisation will be done if needed then Final selection of medicine will be done after consulting the homoeopathic Materia medica Potency, dose and repetition of medicine will be decided according to homoeopathic principles General management such as personal hygiene and proper lifestyle modification will be advised to each and every patient. Swab transferred to Pathology lab of National Institute of Homoeopathy for the culture in nutrient agar plate and which usually takes 36-48 hours. After 48 hours, Gram staining will be done to know the predominate microbes. Biochemical test will be done of that predominate microbes in the Pathology lab, to know the species. Monthly follow up will be done monthly at least for 3 months. Data from Hay’s classification of Nugent score and VSQ21 score will be collected at baseline and after 3 months of study. After collection of desired samples and after knowing the predominate organism antimicrobial study will be done with the given medicine which is found effective.
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
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients suffering from symptoms of vaginal white discharge.
- •Patient who’s satisfying the Amsel’s criteria.
- •Patient age group 15-49 years of female, of any religion, of any socio-economic background.
- •Patents who know and understand either Hindi or English or Bengali.
- •Patients who are willing to give assent and/or consent.
- •Patients who are willing to give consent for clinical examination and sample collection.
排除标准
- •Patients suffering from other infectious disease like trichomoniasis, candidiasis.
- •Patient who’s taking OCPs, who’s Pregnant and lactating.
- •Patient who are already taking homoeopathic treatment for any other chronic disease.
- •Patient suffering from any life threatening/ Psychiatric/ systemic illness or Immunocompromised state or other significant disease conditions.
- •Substance abuse and/or dependence.
- •History of antibacterial therapy within two weeks prior to their attendance.
- •Women with genital malignancy excluded from the study.
结局指标
主要结局
Assessment of change in the symptoms will be recorded on the basis of score either increase or decrease obtained by VSQ21 and Hay’s classification system with Nugent scoring.
时间窗: baseline and 3rd month
次要结局
未报告次要终点
研究者
Priyanka chourasia
National Institute of Homoeopathy kolkata