CTRI/2024/04/065391已完成2 期
An Open Label, Randomized, Controlled Clinical Study to Evaluate the Therapeutic Efficacy of a Specific Unani Formulation in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in Fatty liver grade assessed by QUS.
研究概览
简要总结
Patients of Non-Alcoholic Fatty liver Disease upto Grade II, fulfilling the Inclusion criteria and Exclusion criteria will be divided into two groups.
Group A patients will be given Unani formulation in a dose of 2 capsules twice daily orally in empty stomach for 90 days.
Group B patients will be given Vitamin E in a dose of 400 mg orally twice daily for 90 days.
The assessment of Primary objective (Fatty liver) will be done through QUS (Quantification Ultra Sound) on day 1 and day 90.
The assessment of LFT and Lipid profile will also be done on day 1 and day 90 to see the effect on secondary objectives.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of grade 1 and grade 2 Fatty Liver (up-to 290 db/m in QUS/ Fibroscan)
- •Patients willing to participate and ready to sign the written informed consent.
- •Patients diagnosed as having fatty liver based on the ultrasonography report.
- •Patients with/ without clinical signs and symptoms.
排除标准
- •Patients having documented fatty liver grade 3 or above.
- •Use of alcohol or any other drug abuse.
- •Patients diagnosed with any coexisting liver disease.
- •Pregnant and lactating women.
- •Patients suffering with Hypertension, CKD, CAD, CLD or uncontrolled DM, Hypothyroidism.
- •Patient having immune-compromised status.
- •Patient using lipid lowering drugs or dietary supplements within the last 3 weeks.
- •Oral contraceptives & corticosteroids.
- •Neurological disorders like epilepsy or psychiatric disorders.
- •Acute hepatitis with raised serum bilirubin.
结局指标
主要结局
Improvement in Fatty liver grade assessed by QUS.
时间窗: 1st day and 90th day
次要结局
- Improvement in Liver Function Test,(Improvement in Lipid profile)
研究者
Md Wasi Akhtar
Jamia Hamdard
研究点 (1)
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