Effect of Ayush PTK on metabolic parameters, and hepatic steatosis or fibrosis in Metabolic dysfunction associated steatotic liver disease: A Randomised controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Fraction of patients achieving greater than 30% MRI-PDFF change in each arm (responders)
研究概览
简要总结
The overall prevalence of NAFLD/MASLD in India is 38.6% among adults and 35.4% among children. Studies suggest that the prevalence of MASLD in Indian urban and rural populations is higher than the average estimated global prevalence of 25%. The entity of NAFLD encompasses a spectrum from simple steatosis to non-alcoholic steatohepatitis (NASH), which can progress to liver fibrosis, cirrhosis, and HCC. The treatment options for NAFLD/MASLD include diet and exercise, which are associated with poor compliance. Apart from control of comorbidities, including control of diabetes, the only available approved drug is Resmetirom. This drug has been approved by the U.S. FDA recently for managing patients with noncirrhotic nonalcoholic steatohepatitis (NASH or MASH) and moderate-to-advanced hepatic fibrosis. This drug has not been tested in the Indian population and is not available in India. There is an unmet need for therapeutic options for NAFLD/MASLD which affects almost 25% of the global population.
In this proposal, we plan to study the Prakriti of patients with NAFLD/MASLD and correlate it with long-term outcomes. We also plan to conduct RCTs to assess the efficacy of Ayurvedic therapies in patients with NAFLD/MASLD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with NAFLD/MASLD with elevated liver enzymes with or without fibrosis
- •Willing to give written consent for the study.
排除标准
- •Cirrhosis
- •Presence of other etiologies for fatty liver, eg alcohol, drugs, viral infections, autoimmune hepatitis
- •Uncontrolled diabetes
- •BMI greater than 35
- •AST or ALT greater than 5 times normal
- •Patients on Vit E, Saraglitazor, SGLT-2
- •Patients on Pioglitazone
- •Patients planned for Bariatric surgery or post-bariatric surgery
- •Planned for endoscopic interventions
- •Patients on bile acid chelators/ursodeoxycholic acid/obeticholic acid.
结局指标
主要结局
Fraction of patients achieving greater than 30% MRI-PDFF change in each arm (responders)
时间窗: 1 year
次要结局
- 1. Change in liver enzymes- AST and ALT(2. Changes in BMI of patients in both arms (at baseline and at end of 1 year))
研究者
Dr Shalimar
All India Institute of medical Sciences