CTRI/2012/01/002377招募中2 期
Clinical Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Obesity (Sthaulya) - ACT- OB-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. Patients of either sex with age between 18 and 65 years.
- •2. BMI >=30 kg/m2 and < 40 kg/m2
- •3. Willing and able to participate in the study for 16 weeks.
排除标准
- •1. Intake of over the counter weight loss agents, centrally acting appetite suppressants in
- •the previous six months.
- •2. Pathophysiologic/ genetic syndromes associated with obesity (Cushingâ??s syndrome,
- •Turnerâ??s syndrome, Prader willi syndrome).
- •3. Patients with evidence of malignancy
- •4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
- •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
- •7. Patients suffering from major systemic illness necessitating long term drug treatment
- •(Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
- •8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
- •Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •9. Symptomatic patient with clinical evidence of Heart failure.
- •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 and/or drug abusers.
- •12. Prior surgical therapy for obesity
- •13. H/o hypersensitivity to any of the trial drugs or their ingredients.
- •14. Pregnant / lactating woman.
- •15. Patients who have completed participation in any other clinical trial during the past
- •six (06) months.
- •16. Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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