| CTRI Number |
CTRI/2019/03/017956 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2023 |
| 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 clinical study to evaluate the effect of AfperFit on body fat loss in overweight subjects |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel-group, clinical study to evaluate the thermogenic effect of AfperFit on body fat loss in overweight subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Room No:1,Department of general medicine,Aman Hospital and Research Centre Pvt Ltd. 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
amankhanna11974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
No 9 , Myhthri Legacy Ist Floor 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 Private Limited |
| Address |
No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs (P) Ltd,No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Private Limited |
| Address |
No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
| Type of Sponsor |
Other [Manufactureres 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 Aman Khanna |
Aman Hospital and Research Center |
Room No: 1, Department of General medicine, 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT |
990402122
amankhanna11974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aman Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Afperfit |
250mg capsules twice a day for 84 days |
| Comparator Agent |
Placebo |
250mg capsules twice a day for 84 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and Female Subjects
2 Overweight Subject: BMI ≥ 25.0 to < 30.0 kg/m2
3 Subject willing to adhere with their routine diet and exercise regimen throughout the study.
4 Must be willing and able to give informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1 Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease)
2 Subjects with fasting blood sugar above the normal limits during screening
3 History of
Chronic metabolic disease
Psychiatric illness
Drug abuse, smoking, abuse/addiction to alcohol
Eating disorder such as bulimia or binge eating
Endocrine abnormalities including stable thyroid disease
History of any major surgery, including cardiovascular surgery and bariatric surgery
4 History of allergic reaction to contrast dye, herbal products or any component of the study product
5 Subjects on other therapies such as Homeopathy / Ayurveda
6 Subjects with positive HIV card test during screening
7 Known Hepatitis B positive or any other immuno-compromised state
8 Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subject’s safety and preclude trial participation
9 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
10 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 |
1. Changes in whole body energy expenditure from baseline to end of the study
2. Change in body composition and fat distribution from baseline to end of the study
|
Day 0, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in body weight from baseline to end of the study |
Day o, Day 42, Day 84 |
| Changes in BMI from baseline to end of the study |
Day 0, Day 42. Day 84 |
| Changes in Questionnaire based assessments |
Day 0, Day 42, 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
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet " |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
is a double blind, randomized (1:1), placebo controlled, parallel group, two
arm study. 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 AfperFit or placebo. Subjects will be requested
to adhere with their routine diet and exercise regimen throughout the study.
The
subject will arrive at the study site in a fasted state and blood samples will
be collected for laboratory assessment .
Post
blood sample collection, energy expenditure ,body composition and fat distribution will be assessed Anthropometric measurements recording
(height, weight, BMI, waist circumference, waist to hip ratio) will be
recorded.
|