| CTRI Number |
CTRI/2023/10/058501 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
01/11/2023 |
| 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, Double-Blind, Parallel Group Clinical Study To Evaluate Efficacy And Safety Of UO ABG 01 In The Management Of Borderline Cardio Vascular Risk Factors |
|
Scientific Title of Study
|
A randomized, double-blind, parallel group clinical study to evaluate efficacy and safety of UO ABG 01 in the management of borderline cardio vascular risk factors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1.0 |
Other |
| 23 June 2023 |
Other |
| XLS-CVD/ UOABG01-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R VaniRaj |
| Designation |
Principal Investigator |
| Affiliation |
Chennai Meenakshi Multispeciality Hospital |
| Address |
Chennai Meenakshi Multispeciality Hospital
Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600004
India |
| Phone |
9566229193 |
| Fax |
|
| Email |
rvaniraj.004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Sudha Rani |
| Designation |
Clinical Research Coordinator |
| Affiliation |
Chennai Meenakshi Multispeciality Hospital |
| Address |
Chennai Meenakshi Multispeciality Hospital
Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600004
India |
| Phone |
9566229193 |
| Fax |
|
| Email |
clinsolve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Sudha Rani |
| Designation |
Clinical Research Coordinator |
| Affiliation |
Chennai Meenakshi Multispeciality Hospital |
| Address |
Chennai Meenakshi Multispeciality Hospital
Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600004
India |
| Phone |
9566229193 |
| Fax |
|
| Email |
clinsolve@gmail.com |
|
|
Source of Monetary or Material Support
|
| Xtractiva Life Science Private Limited |
|
|
Primary Sponsor
|
| Name |
Xtractiva Life Science Private Limited |
| Address |
8/946, Navaratna House Jawahar Road Mattancherry, Kochi Ernakulam, 682002, Kerala, 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 |
| P Sudha Rani |
Chennai Meenakshi Multispeciality Hospital Limited |
Old No 149, new No 70, Luz Church road, Mylapore, Chennai, Tamil Nadu
Chennai
TAMIL NADU |
9566229193
clinsolve@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chennai Meenakshi Multispeciality Hospital Ltd. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo is a 500 mg capsule with no therapeutic effect
will be given to subject for 84 days once daily |
| Intervention |
UO ABG 01 |
UO ABG 01 is a 500 mg capsule containing Garlic extract will be given to subject for 84 days once daily |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female subjects between 25 to 65 years of age
Ability to understand the risks/benefits of the protocol
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
Serum triglycerides > 115mg/dL and less than < 199 mg/dL
If former smoker (previously smoked ≥10 cigarettes/day for at least 1 year, cessation for at least 6 months
Willing to give written informed consent and willing to comply with trial protocol
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from Baseline to End of the study in
• Serum triglycerides
• Serum HDL
• Serum LDL
• Total Cholesterol
|
Day -7, Day 28, Day 56 and Day 84
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from Baseline to End of the study in
• Blood Pressure
• Fasting blood glucose
|
Day -7, Day 28, Day 56 and 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)
|
20/10/2023 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 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 the management of borderline cardio vascular
risk factors. |