CTRI/2020/02/023571尚未招募3 期
A prospective, randomized, double-blind, placebo controlled clinical trial to evaluate the efficacy and safety of Garcinol 20% in reducing the risk of metabolic syndrome in obese individuals.
Sami Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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 subjects aged between 21 to 55 years both inclusive.
- •2 BMI greater than or equal to 29 Kg/m2and less than or equal to 40 Kg/m2.
- •3 Willing to take up the walking exercise for a span of 30 minutes daily for 5 days in a week and follow the recommended diet throughout the study.
- •4 Subjects agree to maintain a diary on food consumption and exercise.
- •5 Able to give written informed consent.
- •6 Willing to come for regular follow-up visits.
排除标准
- •1 Intake of prescribed drugs in Ayurveda, Homeopathy, Naturopathy, Allopathy etc. or prior surgery for obesity in the previous six months.
- •2 Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome,Turnerâ??s syndrome, Prader-Willi syndrome).
- •3 Alcoholics
- •4 Subjects with evidence of malignancy.
- •5 Subjects having history of diabetes (Type I or Type II); with the fasting blood glucose >=126 mg/dl and HbA1c > 6.5%
- •6 Subjects with history of clinically diagnosed Hypertension and with BP > 140 / 90 mm of Hg.
- •7 Subjects diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 mIU/L.
- •8 Subjects on lipid lowering drugs.
- •9 Subjects having history of underlying inflammatory arthropathy, septic arthritis,
- •inflammatory joint disease, gout, pseudo gout, Pagetâ??s disease, joint fracture,acromegaly, fibromyalgia, Wilsons disease,Ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
- •10 Subjects having history of coagulopathies, cardiovascular diseases, congestive heart failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness,
- •peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD].
- •11 Have been diagnosed with an eating disorder, such as anorexia nervosa, bulimia nervosa, binge eating disorder or nocturnal eating disorder.
- •12 History of any psychiatric disorders like schizophrenia or bipolar disorder.
- •13 Weight loss (±5%) in last 6 months.
- •14 Subjects 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.
- •15 Subjects 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 for females or >1.4 mg/dL for males and EGFR of 60 or less).
- •16 History of hypersensitivity to any of the herbal extracts or dietary supplement.
- •17 Pregnant / lactating woman.
- •18 Subjects who have completed participation in any other clinical trial during the last three months.
- •19 Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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