CTRI/2021/09/036495招募中未知
A prospective, randomized, double-blind, placebo controlled clinical study to evaluate the efficacy and safety of CALEBIN-A in reduction of weight and management of metabolic syndrome.
试验速览
- 阶段
- 未知
- 状态
- 招募中
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. IDF (International Diabetes Federation) 2006:
- •Waist ââ?°Â¥ 90 cm (men) or ââ?°Â¥ 80 cm (women) along with the presence of minimum two or more of the following:
- •a. Fasting blood glucose greater than equal to 5.6 mmol/L (100 mg/dl) or diagnosed diabetes
- •b. HDL cholesterol < 1.0 mmol/L (40 mg/dl) in men, < 1.3 mmol/L (50 mg/dl) in women or drug treatment for low HDL-C
- •c. Blood triglycerides > 1.7 mmol/L (150 mg/dl) or drug treatment for elevated triglycerides
- •d. Blood pressure > 130/85 mmHg or drug treatment for previously diagnosed hypertension.
- •2. Male and/or female subjects aged between 30 to 65 years (both inclusive) with valid age proof.
- •3. BMI (ââ?°Â¥) greater than or equal to 28 kg/m2 and less than or equal to 35 kg/m2.
- •4. Willing to take up regular physical activity (for example: walking for a span of 30 minutes daily for 5 days in a week).
- •5. Subjects willing to agree for blood draws as per the protocol.
- •6. Able to give written informed consent.
- •7. 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 (Cushingââ?¬•s syndrome, Turnerââ?¬•s syndrome, Prader-Willi syndrome).
- •3. Subjects who disagree to avoid drinking alcohol during study period.
- •4. Subjects with diagnostic history of malignancy.
- •5. Fasting Blood Glucose ââ?°Â¥ 150 mg/dl and HbA1c > 7%.
- •6. Subjects with history of clinically diagnosed Hypertension and with BP > 160 / 100 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, Pagetââ?¬•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 Disorder [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 3 months.
- •14. Subjects on prolonged ( > 4 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 six months.
- •19. Any other condition which the Principal Investigator thinks may jeopardize the study.
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