| CTRI Number |
CTRI/2019/08/020736 [Registered on: 16/08/2019] Trial Registered Prospectively |
| Last Modified On: |
28/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety Study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
In this study the safety of Pterostilbene will be assessed against an inert substance in healthy human volunteers. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo controlled study to evaluate clinical safety of Pterostilbene in healthy volunteers. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CPL/75/PTS/DEC/18V3.010-APR-20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Balachandra |
| Designation |
Professor & Head of Department |
| Affiliation |
BGS Global Institute of Medical Sciences & Hospital |
| Address |
Department of General Medicine
#76,BGS Health & Education City, Uttarahalli Road, Kengeri, Bangalore-560060.
Bangalore
KARNATAKA
560060
India |
| Phone |
9845111559 |
| Fax |
|
| Email |
drgbalachandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.
560058
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.
560058
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
|
Source of Monetary or Material Support
|
| Sami Labs Limited
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore. |
|
|
Primary Sponsor
|
| Name |
Sami Labs Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore. |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients & standardized herbal extracts and nutritional supplements.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Balachandra |
BGS Global Institute of Medical Sciences & Hospital |
Department of General Medicine,
#76, BGS Health & Education City, Uttarahalli road, Kengeri, Bangalore.
Bangalore
KARNATAKA |
9845111559
drgbalachandra@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Divakars Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Body mass index range 18 to 30 kg/m2 |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One 100 mg capsule before breakfast and after dinner for 60 days. |
| Intervention |
Silbinol® 90 % |
One 100 mg capsule before breakfast and after dinner for 60 days. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
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 & 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
Modification(s)
|
| Outcome |
TimePoints |
| 1 Glutathione, Malondialdehyde and Superoxide dismutase |
1 Glutathione, Malondialdehyde and Superoxide dismutase(Day0 & Day60) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |