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临床试验/CTRI/2015/11/006333
CTRI/2015/11/006333尚未招募2 期

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE ROLE OF DIET THERAPY AND VYOSHADI SAKTU IN OBESITY

Government Ayurveda Medical college Mysore0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60

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

  • Elevated levels of lipid profile
  • BMI between >30 to 40kg/m2
  • Willing to come for regular follow-up visits
  • Able to give written information consent

排除标准

  • Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months
  • Pathophysiological/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader willi syndrome)
  • Patients with evidence of malignancy
  • Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
  • Patients with poorly controlled Hypertension ( >160/100 mm Hg)
  • Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study
  • Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc.)
  • Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infraction, Stroke or Severe Arrhythmia in the last 6 months
  • Symptomatic patient with clinical evidence of Heart failure.
  • Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2.5 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.
  • History of HIV and other viral infections
  • Alcoholics and/or drug abusers
  • Prior surgical therapy for obesity
  • History of hypersensitivity to any of the herbal extracts or dietary supplements.
  • Pregnant/ lactating women.
  • Patients who have completed participation in any other clinical trial during the past six (03) months.
  • Any other condition which the principal investigator thinks may jeopardize the study

研究者

发起方
Government Ayurveda Medical college Mysore

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