A randomised double-blind placebo controlled study to evaluate the effect of Punarnavashtak Ghana along with Lifestyle modification in Metabolic associated Fatty liver disease (MAFLD) with special reference to Yakrit Vikar
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To study effect of Punarnavashtak Ghana with life style modification in comparision with placebo with life style modification on the basis of subjective parameter from baseline to end of study.
研究概览
简要总结
This study is a randomizes double-blind placebo controlled clinical trial designed to evaluate the effect of Punarnavashtak Ghana a classical ayurvedic formulation along with lifestyle modification in the management of Metabolic Associated Fatty Liver Disease (MAFLD) with special reference to Yakrit Vikar as described in ayurveda.
The study aims to assess the imapact of Punarnavashtak Ghana on the basis of subjective and objective criteria and the diagnosis will be done on the basis of three phase screening-
Phase 1 screening-
At least one of the following criteria-
1.Obesity/overwight(BMI)>25 kg/m2 with symptoms
2.Presence of type 2 diebetes mallitus
3.Metabolic dysregulation defined by the presence of at least two of the seven metabolic risk criteria-
Phase 2 screening-
for Metabolic Dysregulation at least 2 of the 7 metabolic risk criteria
1.waist circumference >94 cm in male and >80 cm in women
2.BP >130/85 mmhg
3.plasma tryglyceride >150mg/dl
4.HDL cholestrol <40mg/dl for men and <50 mg /dl for women
5.Homa insulin resistance score>2.5
- Plasma CRP >2mg/dl
7.Prediebetes
Phase 3 screening-
USG (abdomen)-Grade 1 to grade 2 Fatty liver changes
After the diagnosis the medicine should be administered to the patients and the outcome will be noted on the basis of subjective and objective criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient of either sex between the age of 18 to 65 year.
- •2.Patients fulfilling diagnostic criteria as mentioned in brief summary.
- •3.Sonologically diagnosed and fresh cases with grade 1 and grade 2 fatty liver .
- •4.Patient who are willing for participation in the trial, ready to undergo study related procedures and fill the consent form.
排除标准
- •1.Alcoholic steatohepatitis 2.K/C/O hepatitis B and C, cirrhosis of liver, Jaundice 3.Pregnant and lactating women.
- •4.The prescription of medication which would cause MAFLD ex.tamoxifen 5.Already taking supplementary medicine for NAFLD 6.Patient who has past history of cardiac Arrythmia, Acute coronary syndrome, myocardial infarction, symptomatic patient with clinical evidence of cardiac failure.
结局指标
主要结局
To study effect of Punarnavashtak Ghana with life style modification in comparision with placebo with life style modification on the basis of subjective parameter from baseline to end of study.
时间窗: 0 DAYS 30 DAYS 60 DAYS 90 DAYS
次要结局
- To study the the effect of Punarnavashtak Ghana with life style modification in comparision with placebo on 1.Lipid profile(2.SGOT (AST), SGPT(ALT) levels)