CTRI/2012/05/002640招募中2 期
Clinical Evaluation of Palashaa Kshara and Pashanbheda Kwatha Churna in the Management of Urolithiasis - ACT- URO-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 of either sex aged 18-65 years
- •2. Radiological / Ultrasonological evidence of single calculus / multiple calculi < 10 mm each, present in kidney(s)/ ureter(s) / urinary bladder.
- •3. Willing and able to participate for 16 weeks
排除标准
- •1. Urinary Tract Infection (UTI)
- •2. Patients with obstructive uropathy
- •3. Patients with known metabolic/endocrinal disorder favouring calculus formation.
- •4. Patients with evidence of malignancy.
- •5. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%).
- •6. Patients suffering from major systemic illness necessitating long term drug .treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •7. Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •8. Symptomatic patients with clinical evidence of Heart failure.
- •9. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
- •10. 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.
- •11. 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).
- •12. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease or any other condition that may jeopardize the study.
- •13. Alcoholics and/or drug abusers.
- •14. H/o hypersensitivity to any of the trial drugs or their ingredients.
- •15. Patients who have completed participation in any other clinical trial during the past six (06) months.
- •16. Pregnant or lactating woman.
- •17. Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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