A clinical study of Individualized Homoeopathic treatment in the management of Benign Prostatic Hyperplasia using the International Prostate Symptom Score.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To ascertain the effectiveness of Individualized Homoeopathic medicines in cases of BPH and clinically assess the outcome by using IPSS, BII (BPH Impact Index) which is a Quality of Life index, every 15 days.
研究概览
简要总结
This is a Non-randomized study to assess the effectiveness of Individualized Homoeopathic Medicines in the treatment of Benign Prostatic Hyperplasia (BPH) by using clinical assessment tools like the International Prostate Symptom Score (IPSS) and a QoL index known as the BPH Impact Index (BII) along with a Radiological investigation modality, USG Pelvis before and after the treatment to confirm the variation in the PVR volume post the 3-month treatment period.
30 patients will be enrolled into the study at BVDUHMC, Pune.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients who fulfill the case definition.
- •Patients aged 40 years and above will be included in the study.
- •Only symptomatic patients will be taken into the study.
- •Patients without any advanced systemic illnesses.
- •Patients willing to participate in the study and willing to sign the informed consent.
排除标准
- •Patients with IPSS score of greater than 20 (severe BPH) requiring surgical intervention.
- •Patients with Hematuria will not be taken into the study.
- •Patients with Vesical Calculi (Urinary bladder stones).
- •Patients under any other medications for BPH.
结局指标
主要结局
To ascertain the effectiveness of Individualized Homoeopathic medicines in cases of BPH and clinically assess the outcome by using IPSS, BII (BPH Impact Index) which is a Quality of Life index, every 15 days.
时间窗: The patient will be followed up every 15 days and his IPSS score and BII scores will be recorded every 15 days to assess the effect of the given treatment and the progress of the condition.
次要结局
- To assess the variation in Post-void Residual Volume (PVR volume) by USG pelvis before and after the treatment.(Every patient will be under Homoeopathic treatment for 3 months and USG Pelvis will be recorded before and after the 3 months of treatment to assess the variation in the PVR volume.)
研究者
Sai Bhaskar D
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Homoeopathic Hospital