Liver disease
Conditions
Interventions
This study will be conducted at the Faculty of Medicine, University of Colombo. Healthy volunteers will be recruited by an open advertisement. Healthy volunteers who fulfill the inclusion criteria wil
Sponsors
Link Natural Products (Pvt) Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. The volunteers provides written informed consent before starting the study. 2. Volunteers who are in the age group 18 years to 60 years, healthy as defined by history, examination and systolic and diastolic blood pressure, and those who have normal baseline investigations, those who have normal liver function (serum bilirubin, AST, ALT, ALP, GGT, Serum albumin, FBS, coagulation tests (PT/INR)), renal function (urine full report, serum creatinine), hematological parameters (FBC, ESR), ultrasound scan of liver and liver fibro scan will be recruited to the study. 3. Both male and unmarried female volunteers will be recruited to the study. Any female volunteer planning to get married during the 4 months after recruitment to the study will excluded from the study.
Exclusion criteria
Exclusion criteria: 1. Volunteers with a history of chronic illness such as diabetes mellitus, hypertension, cardiovascular diseases, chronic liver and kidney disease, and any other disease that warrants long term medication (e.g., autoimmune disease). 2. Volunteers who have abnormal baseline investigations by history, examination, systolic and diastolic blood pressure, and those who have abnormal liver function (serum bilirubin, AST, ALT, ALP, GGT, serum albumin, FBS, coagulation tests (PT/INR)), renal function (Urine full report, Serum creatinine), hematological parameters (FBC, ESR), ultrasound scan of liver and liver fibro scan would be excluded from the trial. 3. Volunteers on any medicines, including nutritional, Ayurveda/ herbal supplements. 4. Married women volunteers and any women planning to get married during the 4 months after recruitment to the study. 5. Allergies or allergic reactions to any of the ingredients of LLC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs (Weight/kg, height/m, respiratory rate (breaths/min), heart rate (breaths/min), blood pressure (mm/Hg). [At baseline, 1st month, 2nd month, 3rd month and 4th month] Hematological parameters (FBC & ESR) [ At baseline, 1st month, 2nd month, 3rd month and 4th month] Liver profile (AST, ALT, ALP, GGT, Serum albumin, total bilirubin, total protein, coagulation tests (PT/INR), FBS and HbA1c). [ At baseline, 1st month, 2nd month, 3rd month and 4th month] Renal function (UFR, Serum creatinine, GFR, Na+, K+, Ionized Ca2+, Mg2+ and Uric acid) [ At baseline, 1st month, 2nd month, 3rd month and 4th month] Cardiovascular system (CVS)(ECG, Total cholesterol, Triglyceride, HDL, LDL, VLDL, Total cholesterol /HDL ratio and LDL/HDL ratio) [ At baseline, 1st month, 2nd month, 3rd month and 4th month] Physical examination (Eyes, ears, nose, throat, general appearance, skin, respiratory system, CVS, CNS and abdomen) [ At baseline, 1st month, 2nd month, 3rd month and 4th month] | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who experienced adverse events/adverse reactions. ADR will be assessed by a medical investigator. [Throughout the study period] Acceptability of the product will be evaluated using the validated medication acceptability questionnaire (MAQ). [At baseline, 1st month, 2nd month, 3rd month and 4th month] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Colvin Goonaratne
Consultant Clinical Trials
Outcome results
None listed