CTRI/2023/06/053971招募中2 期
Evaluation of the efficacy & safety of ChandraprabhaVati with Gokshuradi Guggulu in the management of benign prostatic hyperplasia- A randomized, standard controlled clinical trial
Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Goverment of India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Prostate volume > 20 and = 50 gm by Transabdominal ultrasound
- •2. Newly diagnosed case of BPH or who have discontinued any other medication for BPH or related complaints for minimum three months prior to enrollment
- •3. Willing and able to give written informed consent and comply with study procedures
- •4. Willing and able to participate in the study for full three months.
排除标准
- •1. PSA > 4 ng/ml
- •2. Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy, and stent replacement) or other invasive procedures to treat BPH
- •3. Post-void residual volume >250mL (Transabdominal ultrasound)
- •4. history of Acute Urine Retention within three months before screening
- •5. History of confirmed malignancy or cancer of prostate or bladder or has an imminent need for surgery
- •6. Participants with uncontrolled Hypertension with or without medication. (BP= 160/100 mm of Hg)
- •7. Participants with uncontrolled Diabetes mellitus with or without medication (HbA1c > 8%).
- •8. Participants with concurrent serious cardiac dysfunction or Hepatic Dysfunction (defined as AST and/or ALT >two times of the standard upper limit) or Renal Dysfunction as serum creatinine level more than the upper limit of lab value, uncontrolled Pulmonary Dysfunction (Asthmatic and COPD patients) or any other concurrent severe disease.
- •9. Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study
- •10. Participants who are taking Ayurvedic treatment/medicine for any disease condition for the last three months
- •11. Participants with impaired cognition, or with a history or diagnosis of psychiatric illness and neurological disorders, etc
- •12. Subjects who are already taking any other medication for treatment of BPH or any related complaints
- •13. Use of Any other condition that PI may think can jeopardize the study.
研究者
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