CTRI/2015/03/005659进行中（未招募）2 期
Evaluation of Clinical Efficacy and Safety of Brahma Rasayana in Apparently Healthy Elderly Persons. - IMR-RAS
CCRAS New Delhi0 个研究点目标入组 180 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •Criteria for Inclusion :
- •1.Apparently Healthy Male/ Female on clinical examination of age between 50-75 years.
- •2.Patients complaining of general weakness and other vague complaints not including the involvement of any particular system.
- •3.Willing to participate
排除标准
- •1.Patients with evidence of malignancy
- •2.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-endocrinal disorder etc).
- •3.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.
- •4.Symptomatic patient with clinical evidence of Heart failure.
- •5.Uncontrolled Hypertensive (taking more than two drugs)
- •6.Patients on Prolonged ( >6 weeks) medication with corticosteroids, antidepressants, anticholinergics etc. or any other drugs that may have an influence on the outcomes of the study.
- •7.Patients with concurrent serious hepatic disorder (defined as Aspatate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit or Renal Disorder (defined as S. Creatinine > 1.2 mg/dL).
- •8. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD), Inflammatory Bowel Disease, Serve Dementia, Severe Infection(s), Non-ambulatory patients or nay other condition that may jeopardize the study.
- •9.Prostate Specific Antigen (PSA) level >4 ng/mL.
- •10.Alcoholics and/ or drugs abusers.
- •11.Pregnant/ lactating womenâ??s
- •12.Patients suffering from uncontrolled Diabetes {HbAlc >9%)
- •13.HIV positive subjects.
- •14.H/o hypersensitivity to the trial drug or any of its ingredients.
- •15.Patients who have complete participation in nay other clinical trial during the past (06) months.
- •16.Any other condition which the Investigator thinks may jeopardize the study.
研究者
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