CTRI/2015/09/006150招募中2 期
Clinical Evaluation of Certain Ayurvedic Formulations in the Management of Sthoulya (Obesity)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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 above 25years and below 60 years.
- •2.Obese patient having 20% excess weight than desirable weight according to height, sex and age / age adjusted BMI above 85th percentile (Indian standard)
- •3.WHR- Waist Hip circumference Ratio > 0.95 in males & > 0.8 in females.
排除标准
- •1.Age below 25 years and above 60 years
- •2.Obesity secondary to or associated with Hypothyroidism, Hyper tension, Diabetes mellitus, Hyperlipidemia or Cushingâ??s syndrome.
- •3.Pregnancy and lactation.
- •4.Patients who cannot report in person once in 2 weeks in the OPD
- •5.Patients with poorly controlled Hypertension ( >160/100 mmHg)
- •6.Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 8
- •7.Patients who have a past history of Arterial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •8.Symptomatic patient with clinical evidence of Heart failure.
- •9.Known HIV & Viral Hepatitis positive cases
- •10.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.
- •11.Alcoholics, smokers, and/or drug abusers
- •12.H/o hypersensitivity to any of the trial drugs or their ingredients
- •13.Patients who have completed participation in any other clinical trial during the past six months.
- •14.Any other condition which the Investigator thinks may jeopardize the study.
研究者
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