CTRI/2022/09/045790招募中未知
A randomized, double-blind, placebo controlled clinical trial to evaluate the efficacy and safety of an extract from Cyperus rotundus containing Stilbenes for weight management in obese individuals.
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. Male and/female participants age between 21 to 55 years
- •2. BMI (>=) greater than or equal to 30 kg/m2 and less than or equal to (<=) 40 kg/m2.
- •3. Self-reported lack of physical activity and lethargic lifestyle.
- •4. Willing to take up walking exercise for a span of 30 minutes daily for 5 days in a week.
- •5. Participants willing to follow the recommended diet throughout the study.
- •6. Able to give written informed consent and comply with requirements of the trial.
- •7. Ability to swallow and retain oral medications.
排除标准
- •1. Intake of over the counter or prescribed Allopathic/Ayurvedic/ Homeopathic/Naturopathic weight loss medications, centrally acting appetite suppressants in the past three months.
- •2. Previous weight loss surgeries like bariatric surgery procedures (gastric bypass, sleeve gastrectomy, adjustable gastric band, biliopancreatic diversion with duodenal switch etc.).
- •3. On other modulators like special diet, diet control, gym and yoga.
- •4. Pathophysiologic/genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader-Willi syndrome).
- •5. History of chronic smoking (more than 2 cigarettes a day)
- •6. Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
- •7. Patients with evidence of malignancy.
- •8. Patients with diabetes (Type I or Type II) , FBS >= 126 mg/dl and HbA1c > 6.5%
- •9. Patients with Hypertension having BP > 140 / 90 mm of Hg.
- •10. Patients diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 mIU/L.
- •11. Patients on lipid lowering drugs.
- •12. Patients 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.
- •13. Patients 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].
- •14. Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder or nocturnal eating disorder.
- •15. History of severe psychiatric disorders like schizophrenia or bipolar disorder.
- •16. Weight loss (±5%) in last 6 months.
- •17. Patients 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.
- •18. 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 for females or >1.4 mg/dL for males and EGFR <60).
- •19. History of hypersensitivity to any of the herbal extracts or dietary supplement.
- •20. Pregnant / lactating woman
- •21. All females with history of PCOS (Poly Cystic Ovary Syndrome)
- •22. Those who have participated in any other clinical trial within three months from the screening.
- •23. Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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