跳至主要内容
临床试验/CTRI/2016/04/006847
CTRI/2016/04/006847已完成未知

An open label clinical study to evaluate the efficacy and safety of Saberry capsules in adult male or female patients suffering from Non-alcoholic Fatty Liver Disease.

Sami Labs Limited0 个研究点目标入组 24 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1 Patients of either sex, 20 to 60 years of age.
  • 2 Patients with BMI range 25 to 34 kg/m2
  • 3 Patients with diabetes and hyper lipidemia as co morbid conditions.
  • 4 NAFLD patients who are refractive to standard drugs of treatment.
  • 5 Willing to come for regular follow up visits.
  • 6 CAGE Questionnaire score of 0 to 1.
  • 7 Able to give written informed consent.

排除标准

  • 1 Known history of hypersensitivity to herbal extracts or dietary supplements.
  • 2 Duration of jaundice greater than 3 months, steato hepatitis, advanced fibrosis, cirrhosis and other liver enzymes.
  • 3 Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test.
  • 4 Patients who are on immuno modulatory drugs.
  • 5 Ongoing treatment with herbals or allopathic hepato protective drugs.
  • 6 Evidence of several renal, hepatic or hematopoietic disorders or severe cardiac insufficiency as revealed by laboratory investigations.
  • 7 History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing.
  • 8 Ayurvedic formulation or any form of CAM therapy in the preceding 2 months.
  • 9 Any condition that in the opinion of the investigator does not justify the patients inclusion for the study.
  • 10 Patients who underwent liver transplantation.

研究者

发起方
Sami Labs Limited

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