| CTRI Number |
CTRI/2019/10/021584 [Registered on: 09/10/2019] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| 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 RoseFit on weight management in overweight subjects. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel-group, clinical study to evaluate efficacy and safety of RoseFit on weight management 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 Veena R M |
| Designation |
Principal Investigator |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of Pharmacology, #67, BGS Global Institute of Medical Sciences ,Uttarahalli Road Kengeri,
Bangalore
KARNATAKA
560060
India |
| Phone |
|
| Fax |
|
| Email |
drveenarm@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.09. 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 Private Limited |
| Address |
No.09. 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 (P) Ltd,No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs P Ltd |
| 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
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prithviraj Puwar |
Anand Multispeciality Hospital |
Department of Medicine,Gorwa Refinery Rd, beside IOCL Petrol pump, Gorwa,Vadodara, Gujarat 390016
Vadodara
GUJARAT |
886644474
drprithvi82@gmail.com |
| Dr Veena R M |
BGS Global Institute of Medical Sciences |
Department of Pharmacology, 2nd Floor, Medical college Building, Uttarahalli Road Kengeri
Bangalore
KARNATAKA |
9880902005
drveenarm@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics committee |
Approved |
| Maruthi Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Over weight Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Two times a day orally; in morning and night 30 minutes before breakfast and dinner for 84 days |
| Intervention |
RoseFit |
Two times a day orally; in morning and night 30 minutes before breakfast and dinner for 84 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Overweight Subject: BMI ≥ 25.00 to < 30 kg/m2
2.Subject willing to adhere with their routine diet and exercise regimen throughout the study
3.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 (Cushing’s syndrome, Turner’s syndrome, Prader–Willi syndrome).
3 Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months
4 Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease);
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/addiction to alcohol, Bariatric surgery
Eating disorder such as bulimia or binge eating Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery, 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 |
Changes in body weight and BMI from baseline to end of the study (EOS)
Change in body composition and fat distribution (assessed by DEXA) from baseline to EOS-body fat % and lean mass/fat mass ratio |
Day 0, Day 28, Day 56, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Appetite biomarkers ,Visual Analog Scale Scores (VAS) for appetite ,Lipid profile and OGTT levels from baseline to EOS |
Day 0, Day 28, Day 56, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2019 |
| Date of Study Completion (India) |
26/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
RoseFit or placebo, orally, twice a day before meals (breakfast and
dinner).
The subject will arrive at the study site
in a fasted state and blood samples will be collected for laboratory assessment
and safety assessment), The study will be conducted in 4 visits over a period of
12 weeks. There will be a follow up visit at the end of Week 14.
|