None listed
Conditions
Interventions
Intervention1: Silbinol® 90 %: One 100 mg capsule before breakfast and after dinner for 60 days.
Control Intervention1: Placebo: One 100 mg capsule before breakfast and after dinner for 60 days.
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy male and female of 18 to 49 years. 2 Body Mass Index range 18 to 30 kg/m2. 3 In good health as determined by medical history,a screening physical examination,vital signs,clinical laboratory tests, and electrocardiogram measurement. 4 Willing to sign informed consent. 5 Willing to come for regular follow â??up visits.
Exclusion criteria
Exclusion criteria: 1 Pregnant and lactating women and having the intention to be pregnant within six months. 2 Do not agree to avoid drinking alcohol and quit smoking during study period. 3 Any medication prescription or over the counter including vitamins and minerals during the course of the study. 4 History or presence of hepatic or gastrointestinal illness or any other condition that interferes with the drug absorbption or distribution or excretion or metabolism. 5 History of renal or pulmonary or epileptic or hematologic or cardiovascular or neurological or psychiatric illness and immunodeficiency diseases. 6 Blood pressure less than 90/60mmHg and greater than 140/90mmHg. 7 Glycosylated Haemoglobin (HbA1c) 6.2% and Fasting Blood Glucose 110 mg/dL 8 Lipid profile: Total Cholesterol ( > 240 mg/dL) LDL Cholesterol (LDL-C) >150 mg/dL,Triglycerides > 200 mg/dL 9 Thyroid TSH 6.0 µIU/mL 10 History of malignancy. 11 Subject with history of drug abuse or significant alcoholism. 12 Donation or loss of 450ml or more of blood within 3 months prior to Screening or Baseline. 13 Subjects with positive Human immunodeficiency virus test. 14 Positive Hepatitis B surface antigen or Hepatitis C tests. 15 Subjects with concurrent serious hepatic disorder defines as Aspartate Amino Transferase and or Alanine Transferase, Alkaline Phosphatase greater than 1.5 times upper normal limit, Total Bilirubin greater than 1.2 or Renal Disorders defines as Serum Creatinine greater than 1.2mg/dl and EGFR 60 or less. 16 Subject has participated in any clinical trial within last 3 months. 17 Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Adverse Events 2 Vital Signs 3 Electrocardiogram 4 Haematology,Liver Function Tests, Renal Function Tests, Lipid Profile and Thyroid Function Tests 4 Fasting blood sugar & HbA1cTimepoint: 1 Adverse Events(Day30,Day60 & follow up) 2 Vital Signs(Screening,Day0,Day30 & Day60) 3 Electrocardiogram(Screening & Day60) 4 Haematology,Liver Function Tests, Renal Function Tests, Lipid Profile and Thyroid Function Tests(Screening,Day30 & Day60) 4 Fasting blood sugar & HbA1c(Screening & Day60) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Glutathione, Malondialdehyde and Superoxide dismutaseTimepoint: 1 Glutathione, Malondialdehyde and Superoxide dismutase(Day0 & Day60) | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld Private Limited
Outcome results
None listed