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). - NI

Welex Laboratories Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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

发起方

Welex Laboratories Pvt Ltd