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CTRI Number  CTRI/2015/09/006148 [Registered on: 01/09/2015] Trial Registered Prospectively
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   This is single center study wherein the safety and efficacy of DigeZyme® in comparison to placebo will be studied in patients with non ulcer functional dyspepsia and delayed onset muscle soreness (DOMS) 
Scientific Title of Study   A randomized, double blind, placebo controlled, parallel group, single center study to evaluate the safety and efficacy of DigeZyme® in patients with non ulcer functional dyspepsia and delayed onset muscle soreness (DOMS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL/40/DGZ/MAR/15V1.023-JUN-15  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sreedhara V 
Designation  Principal Investigator 
Affiliation  Sparsh Hospital 
Address  No. 146, Infantry Road, Opposite to Police Commissioners Office, Bangalore

Bangalore
KARNATAKA
560001
India 
Phone  9900569760  
Fax    
Email  sreedhara142@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Suresh Karri 
Designation  Senior Manager 
Affiliation  ClinWorld Private Limited 
Address  19/1, 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  suresh@clinworld.org  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian 
Designation  Chief Executive Officer 
Affiliation  Syncretic Clinical Research Services 
Address  No. 4, 5th Cross, 11th Main Road, Vasanthnagar, Bangalore, Karnataka

Bangalore
KARNATAKA
560052
India 
Phone  09972598010  
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
Sami labs Limited 
 
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 and 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 Sreedhara V  Sparsh Hospital  No. 146, Infantry Road, Opposite to Police Commissioners Office
Bangalore
KARNATAKA 		 09900569760

sreedhara142@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sparsh Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia, Non ulcer functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DigeZyme® Capsules  Part 1 : One capsule (50 mg)thrice a day for functional dyspepsia for 60 days Part 2 : One capsule (50 mg) thrice a day for delayed onset muscle soreness for 3 days 
Comparator Agent  Placebo  Part 1 : One capsule thrice a day for functional dyspepsia for a period of 60 days Part 2 : One capsule thrice a day for delayed onset muscle soreness for 3 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Male or female subjects ranging in age from 18 to 75 years (both inclusive) diagnosed as having gastro intestinal disorders by the Investigator
2 Athletes or sports persons with functional dyspepsia
3 Fulfilling Rome III Diagnostic Criteria for Functional Dyspepsia Diagnostic criteria Must include-One or more of the following
a Bothersome postprandial fullness
b Early satiation
c Epigastric pain
d Epigastric burning
AND
No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms
Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
4 Willingness to follow the protocol requirement as evidenced by written, informed consent
5 Willingness to complete study questionnaires
6 Agree not to use any medication prescription and over the counter, including vitamins and minerals, during the course of this study
7 Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range
8 Subject’s assurance that they have not taken antibiotics or other drugs whose primary site of action is in the GIT for a period up to 1 month prior to the start of the study 
 
ExclusionCriteria 
Details  1 Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol
2 Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry
3 Organic gastrointestinal or systemic diseases
4 Diabetes mellitus and cardiovascular problems
5 Volunteers on any other enzyme inhibiting drugs whose primary target is in the GI
6 Use of drugs that interfere with gastrointestinal motility
7 History of hypersensitivity reactions
8 History or presence of significant alcoholism or drug abuse in the past one year
9 Participation in a clinical study during the preceding 90 days
10 Previous abdominal surgery (except appendectomy)
11 Any contraindication to blood sampling
12 Smoking or consumption of tobacco products
13 Blood or blood products donated in past 30 days prior to study supplement administration
14 Female subjects on pregnancy and lactating women
15 Volunteers on any concomitant therapy like homeopathy, ayurvedic etc
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Part 1
1 SF-LDQ
2 NDI–SF
3 Visual Analog Scale
4 Clinical Global Impression
5 Glasgow Dyspepsia Severity Score
Part 2
1 MSQ and Algometer
2 Serum markers
3 Hand held dynamometer
4 Agility run test 		 Part 1
1 SF-LDQ-Visit 1,2,3 and 4
2 NDI SF-Visit 1,2,3 and 4
3 Visual Analog Scale-Visit 1,2,3 and 4
4 Clinical Global Impression-Visit 1,2,3 and 4
5 Glasgow Dyspepsia Severity Score-Visit 1,2,3 and 4
Part 2
1 MSQ and Algometer-Visit 1,2,3 and 4
2 Serum markers-Visit 1,2,3 and 4
3 Hand held dynamometer-Visit 1,2,3 and 4
4 Agility run test-Visit 1,2,3 and 4
 
 
Secondary Outcome  
Outcome  TimePoints 
Part 1
1 Adverse Events
2 Vital Signs
3 Abnormal laboratory investigations
Part 2
1 Adverse Events
2 Vital Signs 		 Part 1
1 Adverse Events-Visit 1, Visit 2, Visit 3 and Visit 4
2 Vital Signs-Screening, Visit 1, Visit 2, Visit 3 and Visit 4
3 Abnormal laboratory investigations-Screening and Visit 4
Part 2
1 Adverse Events-Day1, Day 2 and Day 3
2 Vital Signs-Day 0, Day 1, Day 2 and Day 3 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/09/2015 
Date of Study Completion (India) 03/03/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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   A randomized, double blind, placebo controlled, parallel group, single center study to evaluate the safety and efficacy of DigeZyme in patients with non ulcer functional dyspepsia and delayed onset muscle soreness. The study will be conducted in two parts - Part 1 and Part 2. The efficacy outcomes for Part 1 will include Short form of Leeds Dyspepsia Questionnaire, Nepean Dyspepsia Index, Visual Analog Scale, Clinical Global Impression and Glasgow Dyspepsia Severity Score. After a week wash out period from the last day of follow up visit of Part 1, subjects who are interested to participate in 72 hours delayed onset muscle soreness will be enrolled. The efficacy outcomes for Part 2 will include Muscle Soreness questionnaire, Algometer assessment, hand held dynamometer, Agility run test and Serum markers. The individual subject involvement for Part 1 will be 60 days while that for Part 2 will be 3 days. All adverse events will be recorded.  
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