CTRI/2016/07/007089已完成未知
An open label single group single centre study to evaluate the safety and efficacy of Pterostilbene, Garcinol and Anthocyanin combination for weight management in adult male and/or female obese or overweight patients.
Sami Labs Limited0 个研究点目标入组 36 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
- 36
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 or female patients.
- •2. Age between 20 to 65 years.
- •3. BMI between > 25 to 40 Kg/m
- •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 obesit y (Cushingâ??s syndrome,
- •Turnerâ??s syndrome, Prader willi syndrome).
- •3. Patients with evidence of malignancy.
- •4. Patients with poorly controlled Hypertension ( > 160/100 mm Hg).
- •5. 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
- •6. Symptomatic patient with clinical evidence of Heart failure.
- •7. 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 Serum
- •Creatinine > 1.2 mg/dL, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma
- •and /or Chronic Obstructive Pulmonary Disease [COPD], or any other condition that may
- •jeopardize the study.
- •8. History of HIV and other viral infections.
- •9. Alcoholics and/or drug abusers.
- •10. Prior surgical therapy for obesity.
- •11. History of hypersensitivity to any of the herbal extracts or dietary supplement.
- •12. Pregnant / lactating woman.
- •13. Patients who participated in any other clinical trial during the past six (06) months.
- •14. Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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