CTRI/2012/04/002586招募中2 期
Clinical Evaluation of Kanchanara Guggulu and Varuna Kwath Churna in the Management of Benign Prostate Hypertrophy (BPH). - ACT- BPH-2010
Department of AYUSH Ministry of Health Family Welfare Government of India0 个研究点目标入组 150 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
- 入组人数
- 150
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. Patients with age between 45 and 70 years.
- •2. Patients with American Urology Association (AUA) symptom score > 8 and < 21
- •3. Rectal examination consistent with Benign Prostate Hypertrophy (BPH)
- •4. Prostate volume > 30cc
- •5. Prostate Specific Antigen (PSA) < 4 ng/ml
- •6. Urine flow rate of >5 to <15ml/sec for 2 voids
- •7. Willing and able to participate in the study for 16 weeks.
排除标准
- •1. Patients with severe Benign Prostate H (AUA score >21)
- •2. Patients currently using any other form of medical therapy for BPH/ Hair loss
- •3. Patients with H/O Transurethral Resection of Prostate (TURP)
- •4. Serum Prostate Specific Antigen (PSA) > 4 ng/ml
- •5. Chronic retention of urine (Post voidal urine volume > 150ml)
- •6. Refractory bacteriuria
- •7. Patients with persistent gross haematuria
- •8. Patients with evidence of malignancy
- •9. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
- •10. Patients with poorly controlled Hypertension ( >
- •11. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 160 / 100 mm Hg)
- •12. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
- •13. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •14. Symptomatic patient with clinical evidence of Heart failure.
- •15. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
- •16. Alcoholics and/or drug abusers.
- •17. H/o hypersensitivity to any of the trial drugs or their ingredients.
- •18. Patients who have completed participation in any other clinical trial during the past six (06) months.
- •19. Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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