| CTRI Number |
CTRI/2022/02/039981 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
01/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Randomized, Clinical Study to evaluate Efficacy and Safety of ONLP-15 in the Management of Cardio Vascular disease risk factors |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Parallel Group Clinical Study to evaluate Efficacy and Safety of ONLP-15 in the Management of Cardio Vascular disease risk factors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
A Block 4th Floor Prince Info Park 81-B 2nd Main Road
Ambattur
Chennai
TAMIL NADU
600058
India |
| Phone |
|
| Fax |
|
| Email |
sanjib@olenelife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
A Block 4th Floor Prince Info Park 81-B 2nd Main Road
Ambattur
TAMIL NADU
600058
India |
| Phone |
|
| Fax |
|
| Email |
sanjib@olenelife.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
A Block 4th Floor Prince Info Park 81-B 2nd Main Road
Ambattur
TAMIL NADU
600058
India |
| Phone |
|
| Fax |
|
| Email |
sanjib@olenelife.com |
|
|
Source of Monetary or Material Support
|
| Olene Life Sciences Private Limited
A-Block 4th Floor Prince Info Park 81-B 2nd Main Road
Ambattur Chennai 600 058 India |
|
|
Primary Sponsor
|
| Name |
Olene Life Sciences Private Limited |
| Address |
A-Block 4th Floor Prince Info Park 81-B 2nd Main Road
Ambattur Chennai 600 058 India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 T Mohanasundaram |
Hycare Super Specialty Hospital |
Department: Cardiology
37 razak Garden Road MMDA colony
Chennai
TAMIL NADU |
04423637700
moins1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHENNAI MEENAKSHI MUTTISPTCIATITY HOSPTTAT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aged Garlic extract |
Aged garlic extract capsule to be taken once daily for 84 days |
| Comparator Agent |
Placebo |
Placebo capsule to be taken once daily for 84 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or female subjects between 30 to 65 years of age
2 Ability to understand the risks benefits of the protocol
3 Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
4 Serum triglycerides > 115mg/dL and less than < 199 mg/dL
5 If Former smoker (previously smoked ≥10 cigarettes/day for at least 1 year, cessation for at least 6 months
6 Willing to give written informed consent and willing to comply with trial protocol
|
|
| ExclusionCriteria |
| Details |
Pregnant or breast feeding women
Serum glucose levels higher than 126 mg/dL
Use of cholesterol lowering medication or supplements
Use of blood pressure lowering medication
Subjects having abnormal liver or kidney function tests ALT or AST more than 2 times the upper limit of normal elevated Creatinine, males more than 125 μmol per L females more than 110 μmol per L renal insufficiency thyroid or other endocrine disease
Any other condition that, in the opinion of the investigator would adversely affect the subject s ability to complete the study or its measures
Hypersensitivity to any of the ingredient used in the study supplements
Alcohol consumption exceeding the definition of moderate drinking 2 drinks per day for men or 1 drink per day for women
Subjects participated in any investigational study medication within thirty days prior to screening |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from Baseline to End of the study in
Serum triglycerides
Serum LDL
Serum HDL cholesterol
Total Cholesterol
|
Day 0 Day 28 Day 56 Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from Baseline to End of the study in
Blood Pressure
Fasting blood glucose
|
Day 0 Day 28 Day 56 Day 84 |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rapidly growing prevalence of cardiovascular disease is a major threat for the developed as well as developing world warranting urgent need of intervention. Complementary and alternative medicines are gaining popularity among general population because of their safety profile and easy administration. Garlic, in particular, is considered to be one of the best disease-preventive foods because of its potent and widespread effects. This study is to find out the role of garlic in cardiovascular disease prevention. |