CTRI/2021/08/035359已完成2 期
A prospective, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of Dose for your Liver (Dietary Supplement) in patients with Non-alcoholic Fatty Liver Disease (NAFLD)
Eetho Brands Inc1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月23日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of patients showing improvement in fatty liver grading from baseline based on liver USG
研究概览
简要总结
The current study is designed as a prospective, randomized, double-blind, placebo-controlled, parallel group study in male and non-pregnant female patients with NAFLD. This study involves a screening phase, randomization and treatment phase, and follow-up phase as mentioned below:
Screening phase (Visit 1): -14 days to -1 day
Day of randomization (Visit 2): Day 0
Initiation of treatment: Day 1
Interim follow up visit (Visit 3): Day 31 ±2 days
End of treatment (Visit 4): Day 61 ±2 days
End of study (telephonic safety call): Day 67 ±2 days
Treatment phase: 60 Days
Patients considered eligible will be randomized and enter into treatment phase. A total of 30 patients will be enrolled in the study in a randomization ratio of 1:1 to receive test and its matching placebo products, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to provide written informed consent prior to any study-related activities being performed.
- •Able and willing to comply with the protocol, including availability for all scheduled study visits.
- •Male and Female patients aged between 18 years to 70, both inclusive.
- •Patients diagnosed with fatty liver (grades 1-3) based on liver USG.
- •Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception.
- •Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation).
排除标准
- •Hypersensitivity to contents of Dose for your Liver or related class of drugs or to any of the excipients of the formulation.
- •Fatty liver secondary to alcohol consumption.
- •History of regular alcohol consumption exceeding 14 drinks per week for female subjects or 21 drinks per week for male subjects (1 drink is equal to 5 ounce (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within the previous 6 months from screening.
- •Addicted Alcoholics and- or drug abusers.
- •History or presence of coronary, renal, pulmonary and thyroid disease.
- •AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000 per microleter.
- •Difficulty in swallowing and retaining oral formulation.
- •Known HBsAg positive, Anti HCV and HIV positive, hereditary defects of iron, copper and alpha-1 antitrypsin deficient patients.
- •Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.
- •Patient has condition or is in a situation which, in the investigator’s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patient’s participation in the study.
- •Participation in any other clinical study within 30 days before the first dose of Investigational Product.
- •Pregnant or Lactating female patient.
结局指标
主要结局
Percentage of patients showing improvement in fatty liver grading from baseline based on liver USG
时间窗: from baseline to day 60
次要结局
- Change in fatty liver grading based on liver USG(AST to Platelet Ratio Index (APRI))
- Safety Outcome: Number and types of adverse (AEs) and serious adverse events (SAEs)(from baseline to day 67)
研究者
研究点 (1)
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