In this study the safety of Pterostilbene will be assessed against an inert substance in healthy human volunteers.
Not yet recruiting
- Conditions
- Body mass index range 18 to 30 kg/m2
- Registration Number
- CTRI/2019/08/020736
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
In this study the clinical safety of Pterostilbene will be determined in healthy male and female volunteers aged 18 to 49 years and having body mass index range of 18 to 30 kg/m2. The study duration is for 60 days followed by a telephonic follow up after at least 15 days from the last visit of the subject. The primary objective of the study is to evaluate the safety of Pterostilbene through monitoring of adverse events and change in vitals, electrocardiogram and laboratory parameters in comparison to baseline. The secondary objective of the study us to evaluate the change in antioxidant markers from baseline to the end of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
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 –up visits.
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) < 4 and > 6.2% and Fasting Blood Glucose < 70 and > 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 < 0.35 & > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Adverse Events 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) 2 Vital Signs 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) 3 Electrocardiogram 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) 4 Haematology,Liver Function Tests, Renal Function Tests, Lipid Profile and Thyroid Function Tests 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) 4 Fasting blood sugar & HbA1c 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 Outcome Measures
Name Time Method 1 Glutathione, Malondialdehyde and Superoxide dismutase 1 Glutathione, Malondialdehyde and Superoxide dismutase(Day0 & Day60)
Trial Locations
- Locations (1)
BGS Global Institute of Medical Sciences & Hospital
🇮🇳Bangalore, KARNATAKA, India
BGS Global Institute of Medical Sciences & Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr G BalachandraPrincipal investigator9845111559drgbalachandra@gmail.com