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CTRI Number  CTRI/2023/02/050109 [Registered on: 27/02/2023] Trial Registered Prospectively
Last Modified On: 17/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to see the effect of Shred N Fit in obesity. 
Scientific Title of Study   A multicentered, double blind, Randomized, parallel group, placebo controlled, prospective study to evaluate efficacy and safety of Shred N’ Fit in Obese Subjects. 
Trial Acronym  SNF 
Secondary IDs if Any  
Secondary ID  Identifier 
GHPL-SNF-22-02 version 1.0, dated 12 Jun 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMadhu KumarR 
Designation  Principal Investigator 
Affiliation  K R Hospital 
Address  Department of General Medicine KR Hospital, MMC &RI
Irwin road, Mysore
Mysore
KARNATAKA
570001
India 
Phone  9743105248  
Fax    
Email  drkumarmadhu9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Munshi  
Designation  Director Clinical Operations  
Affiliation  Alchemy Clinical Research Services 
Address  Room No 3, First Floor, Alchemy Clinical Research Services, 38, LIG So. Somalwada Road, Manish Nagar Nagpur

Nagpur
MAHARASHTRA
440037
India 
Phone  9822371703  
Fax    
Email  drabhijit@alchemyclinical.in  
 
Details of Contact Person
Public Query  
Name  Neha Gondhale 
Designation  Head Clinical Operations 
Affiliation  Alchemy Clinical Research Services 
Address  Room No 2, First Floor, Alchemy Clinical Research Services, 38, LIG So. Somalwada Road, Manish Nagar Nagpur

Nagpur
MAHARASHTRA
440037
India 
Phone  9322768717  
Fax    
Email  neha.gondhale@alchemyclinical.in  
 
Source of Monetary or Material Support  
Gangwal Healthcare Pvt Ltd 
 
Primary Sponsor  
Name  Gangwal Healthcare Pvt Ltd 
Address  705, Quantum Towers Quantum Tower, Rambagh Lane, behind State Bank of India, Malad, Nadiyawala Colony 2, Malad West, Mumbai, Maharashtra 400064  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMadhu KumarR  K R Hospital   Department of Medicine, First Floor, Room No 22, Irwin Road Mysore Mysore KARNATAKA Mysore
Nagpur
MAHARASHTRA 		 9743105248

drkumarmadhu9@gmail.com 
Dr Rahul Mahajan  Moraya Multispecialty Hospital  Department of Medicine, Ground Floor, Room No 2, Opposite PMP bus stand, Powerhouse chowk, Chinchwad, Pune 411033
Pune
MAHARASHTRA 		 9822177957

rahulsm87@yahoo.co.in 
Dr Amit Ramesh Porwal  Sunrise Multispeciality Hospital  Department of Medicine, Ground floor, Room no 3, C.S. No 517 A/ 1, Plot No. 71 Eward, Near Hotel K-tree, Shivaji Park, Kolhapur 416001 Kolhapur
Kolhapur
MAHARASHTRA 		 9422410677

amitporwal83@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Excel Hospital Institutional Ethics Committee   Approved 
Institutional Ethics Committe Aster Adhar Hospital  Approved 
Institutional Ethics Committee Moraya Multispeciality Hospital  Submittted/Under Review 
Institutional Ethics Committee Mysore Medical College and Research Institute and Associated Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  1 capsule & 1 protein sachet in the morning for 30 days & 1 capsule & 1 protein sachet in the evening for 30 days 
Intervention  Shred ‘N’ Fit  1 capsule & 1 protein sachet in the morning for 30 days 1 capsule & 1 protein sachet in the evening for 30 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and/or female volunteers aged between ≥18 to 65≥ years.
2. Subjects with BMI ≥ 25Kg/m2 and 34.9≥ kg/m2.
3. Subjects who are willing to do exercise for a span of 30 minutes daily for at least 5 days in a week.
4. Subjects who are willing to follow diet advised by investigator.
5. Subjects who are willing to give Inform consent.
6. Subjects who are willing to come for regular follow-up visits. 
 
ExclusionCriteria 
Details  1. Subjects having intake of over-the-counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months or planning to undergo such surgery within 2 months.
2. History of pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, and Parder- Willi Syndrome).
3. Alcoholics and subjects with substance abuse.
4. Subject with evidence of malignancy.
5. Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, rheumatoid arthritis.
6. Subjects having history of coagulopathies, cardiovascular diseases, asthma.
7. Pregnant and lactating women.
8. Subjects with hepatic and renal failure.
9. Subjects on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
10. Subjects with hypersensitivity to any one ingredient of the drugs.
11. Subjects who have participated in other trial within last 3 months.
12. Any other condition which the principal investigator thinks may jeopardize the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in body weight  Baseline to week 4. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in anthropometric measurements
2. Change in lipid profile
3. Change in quality of life
4.Global assessment for overall improvement by investigator and by patient  		 Baseline to week 4. 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   01/03/2023 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study is designed as Multicenter, double-blind, placebo-controlled study. Subject will be assigned to receive either Shred ‘N’ Fit or placebo. Parameters of anthropometric measurements and quality of life questionnaires will be assessed over the period of 1 month. The study will enroll subjects of age group 18 to 65 years.

A total of 112 cases will be enrolled in two groups (56 each group) with BMI between 25-34.9 Kg/m2.

Where one group will receive the regime of test drug Shred ‘N’ Fit and other group will receive the regime of placebo. Safety parameters like hematology and biochemistry will be assessed.

· Visit 1 (Day -3): Screening Visit

· Visit 2(Day 0): Randomization Visit

· Visit 3(Day 15 ± 2): Follow up

· Visit 4(Day 30 ± 2): EOT/Early termination

AE/SAE will be recorded during the conduct of the study.

 
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