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CTRI Number  CTRI/2016/11/007456 [Registered on: 09/11/2016] Trial Registered Retrospectively
Last Modified On: 10/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   In this study the efficacy and safety of DigeZyme capsules will be studied in comparison to placebo in adult male or female patients suffering from Metabolic Health. 
Scientific Title of Study   A prospective, randomized, double blind, placebo controlled, clinical study to evaluate the efficacy and safety of DigeZyme in the management of Metabolic Health. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL/50/DGZ/JUN/16V1.010-JUN-16  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arasu Mohan 
Designation  General Physician 
Affiliation  Chennai Meenakshi Multispeciality Hospital 
Address  Old#148,New#72,Luz Church Road,Mylapore,Chennai.

Chennai
TAMIL NADU
600004
India 
Phone    
Fax    
Email  cmmhospitals@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kiran Vuppala 
Designation  Senior Manager 
Affiliation  ClinWorld(P)Limited 
Address  19/1 & 19/2,I Main,II Phase,Peenya Industrial Area,Bangalore.

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  kiran@clinworld.org  
 
Details of Contact Person
Public Query  
Name  Mr Sanjib Panda 
Designation  Head Operations 
Affiliation  Ocius Life Sciences Private Limited 
Address  No.325, P H Road, Next to Pachaiyappas College, Aminijikarai, Chennai.

Chennai
TAMIL NADU
600029
India 
Phone  9003580729  
Fax    
Email  sanjib@ociuslife.com  
 
Source of Monetary or Material Support  
Sami Labs Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.560 058. 
 
Primary Sponsor  
Name  Sami Labs Limited 
Address  19/1 & 19/2,I Main,II Phase,Peenya Industrial Area,Bangalore,Karnataka-560 058. 
Type of Sponsor  Other [Marketer & manufacturer of phytonutrients, ayurvedic, herbal extracts, probiotics etc.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arasu Mohan  Meenakshi Multispeciality Hospital  Department of General Medicine,Old#148,New#72,Luz Church Road,Mylapore,Chennai-600004.
Chennai
TAMIL NADU 		 9941902780

cmmhospitals@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chennai Meenakshi Multispeciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Adult male or female patients suffering from Metabolic Health, (1) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DigeZyme®  One capsule thrice a day for 90 days.  
Comparator Agent  Placebo  One capsule thrice a day for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Male and/or female patients.
2 Age between 18 to 65 years.
3 BMI between 30 to 34.9 kg/m2.
4 Willing to come for regular follow-up visits.
5 Able to give written informed consent. 
 
ExclusionCriteria 
Details  1 Intake of over the counter weight loss agents,centrally acting appetite suppressants in the previous 6 months.
2 Pathophysiologic/genetic syndromes associated with obesity.
3 Patients on prolonged medication with corticosteroids,antidepressants,anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
4 Patients suffering from major systemic illness necessitating long term drug treatment.
5 Symptomatic patient with clinical evidence of heart failure.
6 History of HIV and other viral infections.
7 Alcoholics and/or drug abusers.
8 Prior surgical therapy for obesity.
9 H/o hypersensitivity to any of the trial drugs or their ingredients.
10 Pregnant/lactating woman.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Body weight and BMI.
2 Lipid Profile.
3 Stool Analysis.
4 Gut Health Questionnaire. 		 1 Body weight and BMI(Screening,Day45 & Day90)
2 Lipid Profile(Screening,Day45 & Day90)
3 Stool Analysis(Screening & Day90)
4 Gut Health Questionnaire(Day0,Day45 & Day90) 
 
Secondary Outcome  
Outcome  TimePoints 
1 Quality of Life Questionnaire.
2 Adverse Events. 		 1 Quality of Life Questionnaire(Day0,Day45 & Day90).
2 Adverse Events(Day45 & Day90). 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/07/2016 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A prospective, randomized, double blind, placebo controlled study in 60 adult male or female patients with history of metabolic disorders will be conducted to evaluate the efficacy & safety of DigeZyme capsules. The efficacy and safety of DigeZyme capsules. The individual subject participation will be for 90 days. The primary assessments for the study will be body weight and body mass index, serum lipids, stool analysis and gut health questionnaire. The secondary assessments for the study will be quality of life questionnaire and adverse events. Follow up visit will be conducted after at least 15 days. 
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