| CTRI Number |
CTRI/2025/02/080484 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| 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 Safety and Efficacy of Porelis on Weight Management in Overweight Subjects
|
|
Scientific Title of Study
|
A Double Blind, Placebo-Controlled, Randomized, Clinical Study
to Evaluate the Safety and Efficacy of Porelis on Weight Management in Overweight Subjects
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-VH-152, Version 1.0 dated 10 October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashank S Gowda |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
OPD No.3,Ground Floor, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8792516793 |
| Fax |
|
| Email |
drshashank.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, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
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, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Pvt Ltd,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India
|
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd, |
| Address |
Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India
|
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Shashank S Gowda |
BGS Global Institute of Medical Sciences |
OPD No.3,Ground Floor, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
8792516793
drshashank.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
250 mg capsule once a day for 12 weeks |
| Intervention |
Porelis |
250 mg capsule once a day for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Overweight subjects: BMI greater of equal to 25.00 kg per meter sqaure and lesser of equal to 30 kg per meter square 2.Subject willing to adhere with their routine diet and exercise regimen throughout the study 3.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subjects willing and able to give informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1.Subjects having a change in body weight (gain or loss) of 5-10% or a loss of more than 5 kg within the last 3 months 2.Subjects with pathophysiologic or genetic syndromes associated with obesity 3.Intake of over the counterweight loss agents, centrally acting appetite suppressants in the previous six months 4.Subjects with a fasting blood sugar of grater or equal to 126 mg per dL, random blood sugar of greater or equal to 200 g per dL, or patients with diabetes taking oral hypoglycemic agents or insulin 5.Subjects suffering from any other chronic health conditions 6.Subjects allergic to herbal products or any component of the study product 7.Subjects with known HIV or Hepatitis B positive or any other immuno-compromised state 8.Subjects with 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 9.Subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 10.Subjects currently participating or having participated in obesity clinical trial during the last 6 months prior to the beginning of this study 11.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 the body weight, BMI and body fat composition |
Baseline, Day 28, Day 56 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in biomarkers |
Baseline, Day 28 and Day 84 |
| Mean change in lipid profile |
Baseline, Day 28 and Day 84 |
| Mean change in anthropometric parameters |
Baseline, Day 28, Day 56 and Day 84 |
| Safety Assessment |
Baseline, Day 28, Day 56 and Day 84 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
24/02/2025 |
| 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 clinical trial. 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 (1:1) to receive either Porelis or placebo for 12 weeks. Baseline blood samples will be collected for the laboratory assessments and safety assessments. Anthropometric measurements will be recorded. Body composition and fat distribution will be measured by DEXA. Subjects will be dispensed a subject diary and IP on Visit 2 and will be instructed to return for follow-up visits on Day 28, Day 56 and Day 84. |