Health Condition 1: K719- Toxic liver disease, unspecified
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male and female participants aged between 18 and 65 years. 2. Participants diagnosed with DILI as defined by any one of the following: (a) serum AST or ALT More than 5 times upper limit of normal (ULN) or ALP More than 2 times ULN (or pretreatment baseline if baseline is abnormal) on two separate occasions at least 24 h apart (b) total serum bilirubin More than 2.5 mg/dl along with elevated serum AST, ALT, or ALP level or (c) INR More than 1.5 with elevated serum AST, ALT, or ALP. 3.Participants with mild (1+) to moderate (2+) cases of DILI as per Drug-Induced Liver Injury Network(DILIN). 4. Roussel Uclaf Causality Assessment Method (RUCAM) score more than or equal to 3 points. 5. Participants whose treatment regimen (Antitubercular, Antiretroviral, Anticonvulsant and Analgesics) are expected to use at least 3 months from the date of enrollment. 6.Participants who have not participated in any other similar clinical study within the last 3 months of screening. 7. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: a. Has not undergone a hysterectomy or bilateral oophorectomy; or b. Has not attained menopause (Women not menstruating for at least 12 consecutive months). 8.Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion. 9.Participants willingly sign informed consent and follow the study procedure.
Exclusion criteria
Exclusion criteria: 1.Participants with acute viral, autoimmune, alcoholic and non-alcoholic fatty liver disease, or other types of hepatitis. 2. Acute liver failure or liver function decompensation, such as hepatic encephalopathy, ascites for duration less than 26 weeks. 3.Known case of Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus(HCV), Hepatitis E Virus HEV). 4.History of Cirrhosis or its complications (like HCC, Portal HTN, Liver failure). Complications may involve: a. Participants listed for living-related or orthotopic liver transplantation b. Participants with a history of hepatocellular carcinoma (HCC) or history of HCC treatment. c. Evidence of portal hypertension (e.g., low platelet counts, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly. d. Other organ failure due to DILI. 5. Other causes of Steatosis (Wilson Disease, Medications, Severe malnutrition). 6. Other laboratory parameters a. Anemia (Hb less than 8gm/dl) or thrombocytopenia (platelet count below 50,000 platelets per microliter) b. Serum creatinine is more than 1.5 times ULN 7.Participants with uncontrolled clinically significant serious conditions like severe anemia, severe cardiovascular disease, respiratory, hepatic, neurological, psychiatric, or malignancy/bleeding disorder or other major systemic disease or participants with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult. 8.Participants with severe DILI (grade 3+, 4+, 5+) as diagnosed with DILI-N 9.Any other conditions (physical, psychological, or social) that can interfere with the participant s compliance to the study in the opinion of the Investigator. 10.Pregnant, as assessed by UPT & history of amenorrhea or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Phase: 1. Reduction in Serum ALT, AST, ALP, TBil, INR on day 14 ( 3 days) of treatment. 2.Percentage of participants with normalization of serum ALT, AST, ALP, TBil, on day 7( 3 days) and serum ALT, AST, ALP, TBil, INR on day 14 ( 3 days) of treatment. Adjuvant Phase: 1. Percentage of participants with normalization/non-significant LFT parameters(Serum ALT, AST, ALP, TBil, INR) throughout the adjuvant phase (at various visits). 2. Proportion of participants with recurrence of DILI as per LFT assessment (Serum ALT, AST, ALP, TBil, INR) during adjuvant phase. Timepoint: Treatment Phase: Treatment Visits (T-V) Treatment-Visit 1/ (T-V1) / (Day -7 to Day 0): Screening Visit Treatment-Visit 2/ (T-V2)/ (Day 1): Baseline/ Enrollment & Randomization Treatment-Visit 3/ (T-V3)/ Day 7 ( 3 days window period): Local Safety Assessment Treatment-Visit 4/ (T-V4)/ Day 14 ( 3 days window period): End of treatment visit. Adjuvant Phase: Adjuvant-Visit1/(A-V1)/Day1: Start of adjuvant visit Adjuvant-Visit 2/ (A-V 2)/ Day 7 ( 2 days window period): Local Safety Assessment Adjuvant-Visit 3/ (A-V 3)/ Day 14 ( 3 days window period): Follow-Up Visit Adjuvant-Visit 4/ (A-V 4)/Day 28 ( 3 days window period): Local Safety Assessment Adjuvant-Visit 5/ (A-V 5)/ Day 42 ( 3 days window period): Follow-Up Visit Adjuvant-Visit 6/ (A-V 6)/ Day 56 ( 3 days window period): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Phase- 1.Improvement in liver injury symptoms using liver injury symptom evaluation scale. Adjuvant Phase- 1.Assessment of Gastrointestinal Symptom Rating Scale (GSRS). 2.Assessment of liver injury symptoms using liver injury symptom evaluation scale. 3.Assessment of quality of life using questionnaires.Timepoint: Treatment Phase - 1.Treatment-Visit 2/ (T-V2)/ (Day 1)- Baseline/ Enrollment and Randomization 2. Treatment-Visit 4/ (T-V4)/ Day 14 ( 3 days window period)- End of treatment visit. Adjuvant Phase- 1. Adjuvant-Visit 3/ (A-V 3)/ Day 14 ( 3 days window period)- Follow-Up Visit 2. Adjuvant-Visit 5/ (A-V 5)/ Day 42 ( 3 days window period)- Follow-Up Visit 3. Adjuvant-Visit 6/ (A-V 6)/ Day 56 ( 3 days window period)- End of the study | — |
Countries
India
Contacts
Public ContactDr Soorya Nayaran H
Himalaya Wellness Company
Outcome results
None listed