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临床试验/CTRI/2025/11/097833
CTRI/2025/11/097833招募中3 期

A Randomized, Controlled, Open-Label, Clinical Study To Evaluate The Efficacy Of Srikhandasava And Patolakaturohinyadi Kashaya In The Management Of Alcoholic Fatty Liver Grade II

Dr Sunil Kumar1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
200
试验地点
1

研究概览

简要总结

This Study is randomized, controlled, open-label, clinical study to evaluate the efficacy of 24ml twice a day of srikhandasava and 24ml twice a day  of patolakaturohinyadi kashaya for 2 months in 200 patients with alcoholic fatty liver grade ii  that will be conducted in the IPD patients of National College of ayurveda and hospital, Barwala. The primary out come measure will be the reduction in liver fat content and improvement in liver function in patients with Alcoholic Fatty Liver Grade Il. The secondary outcome will be focuses on the alleviation of symptoms and improvement in the quality of life of patients.

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
21.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • The patients between 21-50 years age
  • Patients with history of Alcoholic Fatty Liver Grade II
  • Patients with no known systemic disorders
  • Patients irrespective of sex, religion, socioeconomic status will be included.
  • Patients who are not under medication for any condition including ALDs
  • In case of withdrawal of any participant new patient who fits to the above mentioned inclusion criteria will be included in the study for the completeness and accuracy of the data.

排除标准

  • Patients below 21 years of age and above 50 years of age
  • Patients suffering from other systemic disease that interfere with the prognosis and treatment of disease.
  • Patients suffering from any sort of fatal diseases.
  • Patients with the History of more than 5 years.
  • Patients with Non-alcoholic Fatty Liver (NAFLD).
  • Patients with Alcoholic Fatty Liver Grade I, Alcoholic Fatty Liver Grade III, Alcoholic Hepatitis, Cirrhosis, Liver Failure and any other liver diseases which is not caused by Alcoholic Fatty Liver Grade II.
  • The patients who are already under treatment for AFLD/NAFLD or were under the treatment for the above said conditions from any medical system till minimum two weeks prior to the conduct of the study.

研究者

发起方
Dr Sunil Kumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sunil Kumar

Shri Krishna Ayush University

研究点 (1)

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