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临床试验/CTRI/2012/05/002654
CTRI/2012/05/002654招募中2 期

Clinical Evaluation of Rasayana Effect of Ashwagandhadi Lehya in Apparently Healthy Elderly Persons. - ACT- RAS-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. Apparently Healthy Males / Females of age between 50 and 75 years
  • 2. Willing and able to participate for 16 weeks

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 disorders, 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. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
  • 6. 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.
  • 7. 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).
  • 8. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease, Severe Dementia, Severe Infection(s), Non-ambulatory patient or any other condition that may jeopardize the study.
  • 9. Prostate Specific Antigen (PSA) levels > 4 ng/mL
  • 10. Alcoholics and/or drug abusers.
  • 11. Pregnant / lactating woman
  • 12 Patients suffering from Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% or HbA1c > 6.5%}.
  • 13 H/o hypersensitivity to the trial drug or any of its ingredients.
  • 14 Patients who have completed participation in any other clinical trial during the past six (06) months.
  • 15 Any other condition which the Principal Investigator thinks may jeopardize the study.

研究者

发起方
Department of AYUSH Ministry of Health Family Welfare Government of India

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