Evaluating the effectiveness of Oral Individualized Homoeopathic Medicines Versus Hydrastis Canadensis Tincture as a local application in the treatment of Bacterial Vaginosis: An open label Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. This trial is expected to indicate that individualized homoeopathic medicines will have greater
研究概览
简要总结
This study compares the effectiveness of individualized homoeopathic medicines and local hydrastis canadensis tincture with placebo in treating patients with Bacterial Vaginosis, aged 18-45 years. Patients will be randomly assigned to receive either individualized homoeopathic medicines or local hydrastis canadensis tincture with placebo.The study will measure the outcomes using Amsel’s criteria, Nugent scoring and vaginal discharge assessment form. The results will provide valuable insights into the effectiveness of homoeopathic approaches in treating Bacterial Vaginosis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •women of age group 18-45 years.
- •Women presenting with sign and symptoms of Bacterial Vaginosis as per Amsel’s and Nugent Scoring.
排除标准
- •Pregnancy or Lactation: Women who are pregnant or breastfeeding.
- •Concurrent Vaginal Infections: Presence of other sexually transmitted infections.
- •Severe Comorbidities: Significant medical conditions (e.g., diabetes, immunosuppression) that could affect treatment outcomes.
- •Recent Surgical Procedures: Any recent gynecological surgeries or interventions.
- •Hormonal Treatments: Use of hormonal therapies (e.g., contraceptives, hormone replacement therapy) that may influence vaginal flora.
- •Uncontrolled Medical Conditions: Any uncontrolled systemic conditions that could impact health or treatment efficacy.
- •Allergies to Study Remedies: Known allergies or sensitivities to any homoeopathic remedies being tested.
- •Non-compliance Risk: Individuals who may not adhere to the study protocol or followup requirements.
结局指标
主要结局
1. This trial is expected to indicate that individualized homoeopathic medicines will have greater
时间窗: 11 months
therapeutic benefits as compared to Hydrastis Canadensis in treatment of Bacterial Vaginosis
时间窗: 11 months
次要结局
- 1.This study aims to identify a group of most effective homeopathic medicine in the management of Bacterial Vaginosis(2.The study anticipates that homeopathic medicine will show positive effects by improving Amsel’s criteria and Nugent’s score in the treatment of Bacterial Vaginosis)
研究者
Dr Divya Bharti
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre