Efficacy and safety of Qurs-e-Rewand in Metabolic Associated Fatty Liver Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Reduction of Liver Steatosis Grade and improvement in the Serum concentration of Liver Enzymes.
研究概览
简要总结
At the screening visit, a brief medical history will be acquired from each subject, and general physical and vital parameters, hematologic profiles, and body weight will be recorded. Patients of Metabolic Associated Fatty Liver Disease fulfilling the inclusion criteria will be included in study. Patients will be blinded for the study. Participants will be randomly assigned to either experimental group or control group with a 1:1 group using the random allocation software. In the test group 3 capsules of Qurs-e-Rewand 600 mg each will be given twice daily. Conversely, in the control group wheat flour as a placebo will be given in the same way. At each follow up patients will be assessed clinically for efficacy outcome and safety on objective parameters. The safety of the drugs will be ensured by monitoring the hematological and biochemical tests at baseline and after treatment. The data will be statistically analyzed and compared with appropriate statistical tests. The significant level of p <0.05 will be taken for effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Fatty liver Grade one and Grade two with Any One of the following Criteria.
- •Body Mass Index greater or equal to 23 in Asian.
- •Diagnosed patient of type 2 Diabetes.
- •Or Fatty liver Grade one and Grade two detected by Ultrasound, blood biomarkers with Any two of the following risk factors.
- •Waist circumference greater than or equal to 90 and 80 cm in Asian men and women respectively.
- •Blood pressure greater or equal 130 upon 85 mmHg or specific drug treatment.
- •HDL level less or equal to 40 mg/dl in males, less or equal to 50 mg/dl in females or specific drug treatment.
- •Triglycerides greater or equal to 150 mg/dl or specific drug treatment.
- •Prediabetes that is FBS 100 to 125 mg/dl.
- •Homeostasis model assessment of insulin resistance score greater or equal to 2.
- •Plasma high-sensitivity C-reactive protein level greater than 2 mg/L.
- •Age between 18 to 60 years of either gender.
- •Patient willing to participate and follow the protocol.
排除标准
- •Hepatic steatosis in adults less than 5%.
- •Patients with uncontrolled type 2 Diabetes.
- •(FBS greater or equal to 250mg/dl, PPBS greater than 350mg/dl or HbA1c greater or equal to 10%).
- •Patients with uncontrolled Hypertension greater or equal to160 upon 100 mmHg).
- •Patients with uncontrolled lipid profile Total cholesterol greater than 250 mg/dl, Triglycerides greater than 499 mg/dl, LDL greater than 189 mg/dl, HDL greater than 70 mg/dl.
- •Patients suffering from severe cases of liver disease Serum Bilirubin greater than 10mg/dL, AST and ALT greater than 400U/L.
- •Patients suffering from chronic liver disease and cancer.
- •Severe cases of heart, kidney, lung, or other systemic diseases.
- •Pregnant or lactating female.
结局指标
主要结局
Reduction of Liver Steatosis Grade and improvement in the Serum concentration of Liver Enzymes.
时间窗: 56 days
次要结局
- Assessment of subjective Parameters (Indigestion, Fatigue, Right upper quadrant discomfort, Hepatomegaly)(Assessment of Quality-of-Life, World Health Organization Quality of Life Questionnaire (WHOQOL-BREF).)
研究者
Dr Sabiha Khan
National Institute Of Unani Medicine