A Randomized, Open Label, Active Controlled,Multi-Centre,Prospective Clinical Study to Evaluate the Efficacy and Safety of Ayulite Capsules in Comparison with Marketed Formulation in Liver Disorder Patients with Abnormal Liver Functions Tests (LFTs).
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- 1. Assessment of changes in the serum total bilirubin level from baseline to end of therapy in the two groups.
研究概览
简要总结
It is A Randomized, Open Label, Active Controlled, Multi-Centre, Prospective Clinical Study to Evaluate the Efficacy and Safety of Ayulite Capsules in Comparison with Marketed Formulation in Liver Disorder Patients with Abnormal Liver Functions Tests (LFTs). The study will be conducted at three sites in India. The dose of Ayulite will be 2 capsules twice daily orally after food with water for 60 days or till complete resolution of the condition. The dose of marketed formulation will be 2 tablets twice daily orally after food with water for 60 days or till complete resolution of the condition. The Primary Objectives will be to evaluate changes in the serum total bilirubin level from baseline to end of therapy in the two groups and changes in AST and ALT levels from baseline to end of therapy in the two groups on day Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75. The secondary objectives will be to evaluate changes in the serum total bilirubin, AST and ALT levels from baseline to each study visit, changes in subjective clinical improvement assessment scale, adverse events, adverse drug reactions, safety lab parameters on Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •1.Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent. 2.Diagnosis of hepatic disorder with abnormal LFT and clinical icterus as manifested by one or combination of the symptoms like.
- •dark colored urine, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, indigestion, aversion to smoking, right upper abdominal discomfort, pain or feeling of pressure. 3.Serum total bilirubin level ≥ 2 mg/dL and/or clinically significant increase in ALT/ AST levels (at least more than 2.5 times of normal limits). 4.The subject is able and willing to undertake all study-required Procedures and has ability to take oral medications. 5.Subjects willing to practice effective method of contraception during study period.
排除标准
- •1.Pregnant or lactating women.
- •2.Subject with known hypersensitivity to contents of Ayulite Capsule or contents of marketed formulation.
- •3.Subjects suffering from active Hepatitis B or C.Obstructive Jaundice (diagnosed clinically and biochemically).
- •4.Known case of advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer).
- •5.Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer.
- •6.Current use of any marketed herbal preparation for Jaundice treatment within past two weeks.
- •7.Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study.
- •8.The subject is currently participating/participated in any clinical trial for past 90 days.
结局指标
主要结局
1. Assessment of changes in the serum total bilirubin level from baseline to end of therapy in the two groups.
时间窗: Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75
2. Assessment of changes in AST and ALT levels from baseline to end of therapy in the two groups.
时间窗: Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75
次要结局
- 1.Assessment of changes in the serum total bilirubin, AST and ALT levels from baseline to each study visit.(2.Assessment of changes in subjective clinical improvement assessment scale)