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临床试验/CTRI/2023/10/058382
CTRI/2023/10/058382尚未招募2/3 期

A Comparative Clinical Study of Shigru Kwatha and Livogrit in Yakritvikara (Non Alcholic Fatty Liver Disease)

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月15日最近更新:

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)

研究者

发起方
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
申办方类型
Private medical college

研究点 (1)

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