CTRI/2024/01/061008尚未招募3 期
Efficacy of Yoga in patients with Metabolic dysfunction associated Steatotic Liver Disease - An open label, Non- Inferiority, Randomised Controlled Trial - Nil
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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)Patients with MASLD: defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of Fibroscan) together with the presence of at least one of five cardiometabolic criteria after ruling other causes of hepatic steatosis.
- •2)Overweight and obese patients as per Asia-Pacific criteria (BMI = 23 and = 25Kg/m2) respectively.
- •3)All patients must be on stable doses of medical therapy for hypertension or diabetes for atleast 6 weeks before the study start date.
- •4)Be willing and able to participate in the full program.
- •5)Be willing and able to functionally participate in all activities set as part of the intervention.
- •6)Be able to complete all day-to-day activities and instrumental activities of daily living independently, completely without assistance from others.
- •7)Consent to participate in study.
排除标准
- •1)Patients who are not willing to give consent for the study.
- •2)Patients who will not be able to carry out yoga and exercise protocol safely, recent fall or > 3 falls in a year, recent hospitalization in 1 month, and those who fail to give consent will be excluded.
- •3)The patients with severe cardio-pulmonary disease, coronary artery disease, cardiomyopathy, severe musculoskeletal disease, neuropsychiatric disease, history of cardiovascular accident, active malignancy, hepatocellular carcinoma and, the end-stage renal disease.
- •4)Patients with decompensated cirrhosis or post liver transplant patients
- •5)Pregnant, lactating women
- •6)Patients having prior study enrolment or enrolment in another conflicting study within past 3 months.
- •7)Patients taking weight loss drugs or oral antidiabetic medications (GLP-1 analogues and glitazones) or any pharmacotherapy for NASH (Vitamin E and Saroglitazar).
- •8)Any patient not meeting any part of the inclusion criteria
研究者
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