Health Condition 1: null- Liver Disorders
Conditions
Interventions
Intervention1: AYULITE Capsules: AYULITE Capsules contains Andrographis paniculata, Tecomella undulate, Tephrosia purpurea, Phyllanthus niruri, Eclipta alba, Holarrhena antidysenterica, Glycyrrhiza gl
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in the serum total bilirubin level from baseline to end of therapy in the two groups. 2. Assessment of changes in AST and ALT levels from baseline to end of therapy in the two groups. Timepoint: Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 3.Assessment of adverse events, adverse drug reactions, safety lab parameters Timepoint: Day -3, Day 0, Day 7, Day 15, Day 30, Day 45, Day 60, Day 75 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed