CTRI/2014/05/004633已完成未知
A randomized, parallel group, single center, double blinded, placebo controlled trial to study the safety and efficacy of Cyperus rotundus extract for weight management in obese patients
Sami labs Limited0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 BMI between >= 30 to 40 Kg/m
- •2 Willing to come for regular follow -up visits
- •3 Able to give written informed consent
- •4 Initially self-report a physical activity of less than 30-90 minutes of moderate to vigorous physical activity per week
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 ( greater than 160 / 100 mm Hg)
- •6 Patients on prolonged ( greater than 6 weeks) medication with corticosteroids,antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study
- •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)greater than 2.5 times upper normal limit) or Renal Disorders (defined as S. Creatinine greater than 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 History of HIV and other viral infections
- •12 Alcoholics and/or drug abusers
- •13 Prior surgical therapy for obesity
- •14 History of hypersensitivity to any of the herbal extracts or dietary supplement
- •15 Pregnant/lactating woman
- •16 Patients who have completed participation in any other clinical trial during the past six (03) months
- •17 Other modulators like diet control, gym and yoga
- •18 Any other condition which the Principal Investigator thinks may jeopardize the study
研究者
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