| CTRI Number |
CTRI/2014/09/004962 [Registered on: 03/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
23/04/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate Efficacy and Safety of Nutricharge® S F on Weight Maintenance in Obese Subjects. |
|
Scientific Title of Study
|
A Randomized, Prospective, Double Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nutricharge® S F on Weight Maintenance in Obese Subjects |
| Trial Acronym |
Nutricharge S F |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TW/NSF/010/14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Rajesh |
| Designation |
Consultant Physician |
| Affiliation |
Indo- US Superspeciality Hospital |
| Address |
Indo US Superspeciality Hospital
Shyam Karan Road
Ameerpet
Hyderabad 500016
Tel:04023782378
E-mail:vukkala@gmail.com
Indo US Superspeciality Hospital
Shyam Karan Road
Ameerpet
Hyderabad 500016
Hyderabad
ANDHRA PRADESH
500016
India |
| Phone |
04023782378 |
| Fax |
040-23782376 |
| Email |
vukkala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Dixit |
| Designation |
Medical Director |
| Affiliation |
Trophic Wellness Pvt. Ltd. |
| Address |
Trophic Wellness Pvt Ltd
Number 142 AB Kandivli Industrial Estate
Kandivli (West) Mumbai 400067
Tel No:02228680353
Trophic Wellness Pvt Ltd
Number 142 AB Kandivli Industrial Estate
Kandivli (West) Mumbai 400067
Tel No:02228680353
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02228680353 |
| Fax |
|
| Email |
dixitnutricharge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Arvind Sakhi |
| Designation |
Director |
| Affiliation |
Trophic Wellness Pvt. Ltd. |
| Address |
Trophic Wellness Pvt Ltd
Number 142 AB Kandivli Industrial Estate
Kandivli (West) Mumbai 400067
Tel No:02228680353
Trophic Wellness Pvt Ltd
Number 142 AB Kandivli Industrial Estate
Kandivli (West) Mumbai 400067
Tel No:02228680353
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02228680353 |
| Fax |
|
| Email |
arvindnutricharge@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/s. Trophic Wellness Pvt. Ltd, Mumbai, India. |
|
|
Primary Sponsor
|
| Name |
Ms Trophic Wellness Pvt Ltd |
| Address |
Number 142 AB, Kandivli Industrial Estate,
Kandivli (West), Mumbai 400067. India
Ph:0222868 0353 |
| Type of Sponsor |
Other [Nutritional and and wellness products company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ClinArion Research Pvt Ltd |
Number 51, 3rd Floor, Paigah Colony,
S P Road, Secunderabad—500003
India.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Rajesh |
IndoUS Superspeciality Hospital |
Consultant Physician
Indo- US Superspeciality Hospital,
Shyam Karan Road
Ameerpet,
Hyderabad- 500016.
Tel:040-2378 2378
E-mail: vukkala@gmail.com
Hyderabad
ANDHRA PRADESH |
04023782378
04023782376
vukkala@gmail.com |
| Dr D Ravisekhar Reddy |
Prime Hospitals |
Dr. D.Ravi Sekhar Reddy
Consultant Physician Diabetologist
Prime Hospitals
Behind Mythrivanam
Ameerpet,
Hyderabad-500 038
Tel:04044569999
E-mail: drrsreddy@gmail.com
Hyderabad
ANDHRA PRADESH |
04044569999
drrsreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Prime Hospitals, Behind Mythrivanam,Ameerpet, Hyderabad. |
Approved |
| Institutional Ethics committee, Prime Hospitals, Behind Mythrivanam,Ameerpet, Hyderabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nutricharge s & f Dose is 40 grams and the Placebo Dose is also be 40 grams. |
The Total duration of the study would be 3 months. The patient will visit on Day -31, Day 0 Day 15,Day 30,Day 60 and Day 90. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged between 18 and 65 Years.
2. BMI ≥ 30 and ≤ 47
3. Subjects able to communicate effectively.
4. In the judgment of the Principal Investigator, able to comply with protocol requirements
|
|
| ExclusionCriteria |
| Details |
1. Contraindications or Hypersensitivity to study product or placebo.
2. History or presence of any medical condition or disease according to the discretion of the Investigator.
3. Clinically relevant conditions expected to preclude achievement of exercise recommendation.
4. Current use of vitamin or mineral supplements, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
5. Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
6. Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
7. Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
8. Diabetes mellitus, irritable bowel syndrome, Gastro-esophageal reflux disease, HIV, hepatitis B or C, malignancy, sleep apnea, insomnia (requiring use of sleeping medication more than once weekly), night eating syndrome, Anorexia nervosa, bulimia, of non-specific eating disorder, and serious psychiatric illness
9. Female subjects who are currently pregnant and breast feeding
10. Current diagnosis or history of alcoholism or drug dependence.
11. Currently taking any medication on a regular basis.
12. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| – The change in the anthropometric measurements (Body Mass Index (BMI), body fat analysis and waist circumference) from baseline visit (Phase 2) to after Day 90 ± 3 (Phase 5) of treatment. |
Day 15,30,60 and 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
– Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug.
–The change in Quality of Life from will be identified in general feedback |
Day 0 to 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2014 |
| Date of Study Completion (India) |
Date Missing |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, prospective, double blind, placebo controlled study to evaluate efficacy and safety of Nutricharge® S&F on weight maintenance in obese subjects daily for 12 weeks in 100 patients with Obese that will be conducted in two centers in India. The primary outcome measures will be The change in the anthropometric measurements (Body Mass Index (BMI), body fat analysis and waist circumference) from baseline visit (Phase 2) to after Day 90 ± 3 (Phase 5) of treatment. The secondary outcomes will be Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug.The change in Quality of Life from will be identified in general feedback.
Nutricharge S F Product Composition.
|
Energy
|
136.2 kcal
|
|
Protein
|
15 g
|
|
Carbohydrates
|
15 g
|
|
Sugar
|
0.00 g
|
|
Dietary fiber
|
6 g
|
|
Fat
|
1.8 g
|
|
Garcinia cambogia Extract
|
1 g
|
|
Conjugated Linoleic Acid (CLA)
|
500 mg
|
|
Green coffee bean extract
|
400 mg
|
|