| CTRI Number |
CTRI/2024/09/074196 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| 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 Clinical Study to Evaluate the Cardiovascular Effects, Safety and Tolerability of Investigational Product (NS2129E03) in Overweight Subjects. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo-Controlled, Parallel
Group Study to Evaluate the Cardiovascular Effects, Safety
and Tolerability of Investigational Product (NS2129E03) in
Overweight Subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-NE-133, Version 1.0 dated 23 July 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshith C S |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
OPD 03, Department of General Medicine,Ground Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9741073960 |
| Fax |
|
| Email |
drharshithcs.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt.Ltd. |
| Address |
Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt.Ltd. |
| Address |
Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Natural & Essential Oils Pvt Ltd
No.74/2B, Manandavadi Road,
HD Kote Roadd, Sriramapura,
Mysuru- 570008,
Karnataka |
|
|
Primary Sponsor
|
| Name |
Natural & Essential Oils Pvt Ltd |
| Address |
No.74/2B, Manandavadi Road,
HD Kote Roadd, Sriramapura,
Mysuru- 570008,
Karnataka |
| Type of Sponsor |
Other [Manufacturer of natural plant based formulations] |
|
|
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 Harshith C S |
BGS Global Institute of Medical Sciences |
OPD 03, Department of General Medicine,Ground Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9741073960
drharshithcs.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medial Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NS2129E03 |
Oral administration of single dose of NS2129E03 capsule everyday for 84 days |
| Comparator Agent |
Placebo capsule |
Oral administration of single dose of placebo capsule everyday for 84 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Overweight Subject: BMI greater or equal to 25.00 to less than 30 kg/m2.2)Subject willing to adhere with their routine diet and exercise regimen throughout the study.3)Subjects not undergoing any supplementation for weight management.4)Females of childbearing age, who agree to use approved birth control methods during the study and have negative UPT at screening.5)Must be willing and able to give informed consent and comply with the study procedures. |
|
| ExclusionCriteria |
| Details |
1)Subjects suffering from intractable obesity, had defined weight limits, or had experienced any recent, unexplained weight loss or gain six months prior to screening.2)Pathophysiologic/genetic syndromes associated with obesity.3)Intake of over the counterweight loss agents, centrally acting appetite suppressants in the previous six months.4)Subjects suffering from any chronic health conditions.5)Subjects allergic to herbal products or any component of the study product.6)Known HIV or Hepatitis B positive or any other immuno-compromised state.7)History of Chronic metabolic disease,Psychiatric illness,Drug abuse, smoking, abuse or addiction to alcohol,Bariatric surgery,Eating disorder such as bulimia or binge eating,Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery and History of any major surgery.8)Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.9)Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Lipid Profile and Biomarkers as compared to placebo from baseline to end of the study. |
Baseline, Day 42, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Change in Body Composition and related parameters |
Baseline, Day 42, Day 84 |
| Overall Safety |
Baseline, Day 42, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a double blind, placebo-controlled, randomized, parallel-group study. Adult overweight subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms (50:50) to receive either NS2129E03 or placebo, orally, once a day for 84 days. Biomarkers and Lipid profile will be analysed. Anthropometric measurements will be recorded in every visit. All efficacy and safety assessment blood sample collection and anthropometric measurements will be conducted at all the visits. |