CTRI/2022/03/040819已完成3 期
CLINICAL EVALUATION OF LEKHANIYA GANA KASHAYA AND AROGYAVARDHINI GUTIKA IN THE MANAGEMENT OF MEDOROGA (OBESITY)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
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.Obese subjects of BMI ( >25 to 39.9 kg/m2)
- •2.Obese patients of either sex and of age between 18 – 45 years.
- •3.Willing to participate in the study
排除标准
- •1.Obesity due to secondary causes – Hypothyroidism, PCOD, Cushing’s syndrome etc.
- •2.Patients with poorly controlled Hypertension (BP > 160 / 100 mm Hg)
- •3.Patients with uncontrolled Diabetes Mellitus having HbA1C >8%.
- •4.Patients who are on corticosteroids, Ca++ channel blockers, anti-psychotics, antidepressants, anti-cholinergic, anti-epileptics, immune-suppressants, Hormonal replacement therapy or any other drugs that may have an influence on the outcome of the study.
- •5.Patients with the H/O significant systemic illness which might interfere with the compliance of the trail drug (Rheumatoid arthritis, Tuberculosis, Inflammatory Bowel Disease etc.).
- •6.Patients who have a past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •7.Symptomatic patients with clinical evidence of congestive cardiac failure.
- •8.Known cases of HIV and AIDS & Patients suffering with malignancy.
- •9.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 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)
- •10.Women who are planning for conception / pregnant or lactating.
- •11.H/o hypersensitivity to any of the trial drugs or their ingredients.
- •12.Any other condition which the Investigator thinks may jeopardize the study.
研究者
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