A Comparative Clinical Study of Shigru Kwatha and Livogrit in Yakritvikara (Non Alcholic Fatty Liver Disease)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Subjective criteria
研究概览
简要总结
This study is a open label double arm comparative study , comparing the efficacy of Shigru Kwatha 100 ml twice daily before meal and Livogrit tablet each 500mg 2 tablet twice daily before meal in 40 patients with Yakritvikara that will be conducted in OPD no. 13/14 in Patanjali Ayurvedic hospital, Haridwar. Assessment will be done on the basis of subjective and objective parameter.
Route of administration- Oral Route
Follow up- follow up will be done to observe effects of treatment or any adverse effect on the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient between the age group of 18 to 65 years will be selected.
- •Patient irrespective of gender, religion, occupation and chronicity will be selected for the study.
- •Both fresh and treated cases would be taken for the study.
- •Patient with Grade 1 and Grade 2 fatty liver only will be selected for the study.
- •Individual with controlled Diabetes Mellitus having Grade 1 and Grade 2 fatty liver will be selected for the study.
排除标准
- •1.Pregnant or lactating women will be excluded.
- •Patient who have had Hepatitis B,C or other hepatic viral infection , autoimmune hepatitis and drug induced hepatitis or alcoholic hepatitis will be excluded.
- •Patient with severe complication of the cardiovascular, renal or hematopoietic systems and mental disease will be excluded.
- •Patient will be excluded having decompensated liver disease.
- •Patient with prolonged or a history of ascites , developed Hepatocellular carcinoma Hepatic Encephalopathy , Variceal bleeding will be excluded.
- •Patient with a history of using IFN or antiviral agents or Corticosteroids or Immunosuppresive drugs will also be excluded.
结局指标
主要结局
Subjective criteria
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1. Anorexia
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2. Fatigue
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3. Abdominal pain
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4. Malaise
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5. Indigestion(avipaka)
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6. Polydipsia (pipasa)
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7. Constipation
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8. Vomiting (chhardi)
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9. Fever (mridu jwara)
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10. Flatulence (aanaha)
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11. Tastelessness
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次要结局
- Objective Criteria(1. Ultrasonography whole abdomen)
