Evaluation of composite management of MASLD( METABOLIC [DYSFUNCTION] ASSOCIATED STEATOTIC LIVER DISEASE) with Sarveshwara loha and lifestyle modifications- A randomized placebo controlled clinical study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Placebo along with lifestyle modifications on the basis of clinical parameters
研究概览
简要总结
It has been known for many years that being overweight or obese is associated with hepatic steatosis, hepatocyte injury, liver inflammation, and fibrosis. This was formally recognised by the term "nonalcoholic fatty liver disease which was recently changed to MASLD.
This randomized placebo controlled clinical study to evaluate the clinical efficacy of sarveshwara loha mentioned in a classical ayurveda formullary named bhishajya rathnavali compiled in the 18th century in the context of yakrithpleeha rogadhikara. MASLD as a disease entity closely resembles yakrityddalyudara in its 1st phase. Sarveshwara loha at present is not manufactured in india. So, an attempt is made to manufacture the present formulation and to study its clinical efficacy in the treatment of MASLD along with any ADR
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA Patients of either gender, irrespective of caste, religion, economic status. Patients between the age group of 35yrs & 65 Yrs Patients meeting any one of the following cardiometabolic criteria 1) BMI more than or is equal to 25 kg by meter square [23 Asia] OR WC more than or is equal to 94 cm (M) 80 cm (F) OR ethnicity adjusted 2) Fasting serum glucose more than or equal to 5.6 mmol per L [100 mg per dL] OR 2-hour post-load glucose levels greater or equal to 7.8 mmol per dl [mg per dL] OR HbA1c greater or equal to 5.7 percentage [39 mmol per L] OR type 2 diabetes OR treatment for type 2 diabetes 3) Blood pressure greater or equal to 130 by 85 mmHg OR specific antihypertensive drug treatment 4) Plasma triglycerides greater or equal 1.70 mmol per L [150 mg per dL] OR lipid lowering treatment 5) Plasma HDL-cholesterol greater or equal to 1.0 mmol per L [40 mg per dL] (M) and s 1.3 mmol per L [50 mg per dL] (F) OR lipid Iowering treatment FIB 4 Index score between FO.
- •F2 NAFLD Fibrosis score between FO-F2.
排除标准
- •EXCLUSION CRITERIA Patients associated with major organic and infective pathologies. Pregnancy and Lactating mother. Patient below the age of 35 yrs. and above the age of 65 yrs. Immuno compromised patients.
- •HIV, AIDS Patients with already-decompensated liver disease by clinical or imaging evidence will be excluded. FIB 4 Index score between F
- •F4 NAFLD Fibrosis score between F3-F4.
结局指标
主要结局
Placebo along with lifestyle modifications on the basis of clinical parameters
时间窗: 4 months
Primary Objectives -
时间窗: 4 months
A. To evaluate the effect of composite management of MASLD with Sarveshwara loha and lifestyle modifications on the basis of clinical parameters
时间窗: 4 months
B. To evaluate the effect of composite management of MASLD with Placebo and lifestyle modifications on the basis of clinical parameters
时间窗: 4 months
. To compare the effect of composite management of MASLD between 2 treatment arms Sarveshwara loha and
时间窗: 4 months
次要结局
- Secondary Objectives -
研究者
Dr Rajesh D Pandi K
Parul institute of Ayurveda