CTRI/2016/01/006487已完成未知
A randomized, double blind, placebo controlled, three group study to evaluate the safety and comparative efficacy of Curcuma caesia vs. Cyperus rotundus and Curcuma caesia for weight management in obese or overweight patients.
Sami Labs Limited0 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
- 未知
- 状态
- 已完成
- 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
- •1 Male and or female patients.
- •2 Age between 20 to 65 years.
- •3 BMI between 25 to 40 kg/m2.
- •4 Willing to come for regular follow-up visits.
- •5 Able to give written informed consent.
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, Praderwilli 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 the study.
- •7 Symptomatic patient with clinical evidence of Heart failure.
- •8 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.
- •9 History of HIV and other viral infections.
- •10 Alcoholics and/or drug abusers.
- •11 Prior surgical therapy for obesity.
- •12 History of hypersensitivity to any of the herbal extracts or dietary supplement.
- •13 Pregnant / lactating woman.
- •14 Patients who have completed participation in any other clinical trial during the past six (06) months.
- •15 Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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