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
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