CTRI/2011/12/002276招募中2 期
Clinical Evaluation of Vyaghri Haritaki in the Management of Bronchial Asthma - Nil
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 with age between 18 to 60 years.
- •2.Patient with stable Bronchial Asthma (Tamaka Swasa) (as per WHO GINA Guideline) for at least 6 weeks prior to study entry.
- •3.Positive test of reversibility:
- •Symptomatic patients - an improvement of 60 L/min or >=20% in PEFR, 10 minutes after the inhalation of 200 mcg of Salbutamol.
- •Asymptomatic patients - 60 L/min or >=20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200 mcg of Salbutamol, when assessed after 10 minutes.
- •4.Patient willing and able to participate for 16 weeks.
排除标准
- •1.Patients with PEFR < 50% and/ or FEV1 < 50% of the predicted value.
- •2.Patients with evidence of malignancy.
- •3.Patient with poorly controlled Diabetes Mellitus (HbA1c > 10%).
- •4.Patients with poorly controlled Hypertension (i.e. Systolic > 160 mm of Hg and Diastolic >= 100 mm of Hg)
- •5.Patients on prolonged ( >= 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
- •6.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
- •7.Patients who have a past history of Atrial Fibrillation, 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 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, or any other condition that may jeopardize the study.
- •10.Smoker/alcoholics and/or drug abusers.
- •11.H/o hypersensitivity to the trial drug or any of its ingredients.
- •12.Patients who have completed participation in any other clinical trial during the past six (06) months.
- •13.Pregnancy or lactating women.
- •14.Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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