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CTRI Number  CTRI/2025/02/079926 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
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 trial to assess the safety of DigeSEB Super PB which affects gastrointestinal health in adult population. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel study to evaluate the effect of DigeSEB Super PB on gastrointestinal health in adult population. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AETL/CT/004/2024 Version no. 1, dated 09/01/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Kumar 
Designation  Gastroenterologist 
Affiliation  Gastrocare Multi Speciality Hospital 
Address  Room no. 01, ground floor, E-3/120-121, Arera Colony, 10 1/2 No. Bus Stop, Bhopal

Bhopal
MADHYA PRADESH
462016
India 
Phone  9893056704  
Fax    
Email  sanjaykr.gastro@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhijit Rathi 
Designation  Principle Scientist 
Affiliation  Advanced Enzymes Technologies Limited 
Address  Room no. 1, 5th floor, A wing, Sun Magnetica, LIC, Service Road, Louis wadi, Thane West

Thane
MAHARASHTRA
400604
India 
Phone  9970092220  
Fax    
Email  akrathi@advancedenzymes.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukul Maurya 
Designation  Director, Proclin Research private limited 
Affiliation  Proclin Research private limited 
Address  Room no. 1, 2nd floor, plot no 1, Nevri Hills, Gufa Mandir road, Lalghati, Bhopal, Madhya Pradesh

Thane
MAHARASHTRA
462030
India 
Phone  7032802286  
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
Advanced Enzymes Technologies Limited. 5th floor, A wing, Sun Magnetica, LIC, Service Road, Louis wadi, Thane West, Thane, Maharashtra, 400604 
 
Primary Sponsor  
Name  Advanced Enzymes Technologies Limited 
Address  5th floor, A wing, Sun Magnetica, LIC, Service Road, Louis wadi, Thane West, Thane, Maharashtra, 400604 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sanjay Kumar  Gastrocare Multi Speciality Hospital  01 ground floor, E-3/120-121, Arera Colony, 10 1/2 No. Bus Stop, Bhopal - 462016, Madhya Pradesh
Bhopal
MADHYA PRADESH 
9893056704

sanjaykr.gastro@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Charak Hospital, Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  DigeSEB Super PB  500 mg, one capsule post meal (lunch and dinner), oral route of administration, swallow as a whole with water after having meal, for 30 days. 
Comparator Agent  Placebo  500 mg, one capsule post meal (lunch and dinner), oral route of administration, swallow as a whole with water after having meal, for 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects having (self-reported) dyspepsia.
2. Subject has to fill in GSRS questionnaire form (GSRS will be collected during the screening and
two days prior to consent, provided the subject has reported any symptoms). The person who
reports at least one or more (mild or moderate) symptoms (out of- nausea, vomiting, heartburn,
abdominal pain, headache, breathless, diarrhea or constipation) at least 2 days will be included
in study.
3. Subjects who have mild to moderate symptoms (for mild- 1 to 3, moderate - 4 to 6, and severe - 7 to 9).
4. Normotensive (seated, resting systolic blood pressure less than 140 mm Hg and diastolic blood pressure less than 90 mm Hg).
5. Refrain from caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to visit 3 and 4.
6. Following stable and consistent diet regimen.
7. Subjects willing to give written informed consent and adhere to all the requirements of this
protocol. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating female.
2. Subjects with BMI greater than or equal to 35
3. Subjects who are chronic smokers and alcoholics
4. Subject having known allergy to the ingredients in the test product.
5. Subject having a history of or currently has any gastrointestinal disease or disorder or any
inflammatory bowel condition such as Gastroesophageal reflux disease (GERD), Cohns
disease, short bowel, ulcerative colitis, or irritable bowel syndrome (IBS).
6. Subjects with long-standing or worsening symptoms during the run-in period.
7. Subject has a history of bariatric surgery at any time before the Screening Visit.
8. Subject has a history of any surgery in the past 3 months.
9. Subject on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems.
10. Subject currently taking laxatives or has taken laxatives within the 30 days prior to screening or enrollment.
11. Subject currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening or enrollment.
12. Subject currently taking or has in the past 30 days used GI related probiotics or prebiotics or any digestive enzymes [prescription or over the counter (OTC)]. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (to be filled daily from screening to Day30 plus or minus day 2).
2. Day 1 and Day 30 (Detailed Assessment)- VAS scale for each symptom (bloating, gas, nausea, heartburn) to be recorded at 30 min, 60 min, 90 min, and 120 min after a meal
3. Day 2 to Day 29 (Daily Assessment)- VAS scale for each symptom (bloating, gas, nausea, heartburn, etc.) to be recorded once daily at a consistent time of day (e.g. after the main meal)
4. DQLQ questionnaire (Weekly assessment from Day 1 to 30 plus or minus 2)
5. VAS for pain, stool consistency and frequency (Every day assessment from Day 1 to 30 plus or minus 2)
6. SF-36 questionnaire (Assessment on Day 1, Day 15 and Day 30 plus or minus 2)
7. Postprandial Hunger and satiety scale (Every day assessment from Day 1 to 30, 2hrs after consuming lunch) 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Measure bloating or waist circumference after meal consumption (assessment at 30 min, 60 min, 90 min
and 120 min after meal consumption on Day 1 and Day 30)
Measure waist circumference with a measuring tape (touching skin) at umbilicus parallel to the ground
around the subject. Subjects would breath normally and measurements would be taken at exhalation.
Repeat measurement thrice and take average, report values in cm.
2. Microbiota analysis in an equally distributed sub population of randomly selected 8 subjects from each
arm (assessment on Day 1 and Day 30).
3. Biochemical analysis in blood-
a. General biochemical analysis- lipid profile, HbA1C, sugar profile, fasting Insulin
b. Liver safety profile (AST, ALT, ALP, Total Albumin, Globulin, Albumin or Globulin Ratio)
c. Renal safety profile (Creatinine, Blood Urea Nitrogen (BUN), Uric Acid, eGFR, Electrolytes) 
30 days 
4. Product tolerability
a. Tolerability to investigation product (Questionnaire to be filled daily throughout the study duration).
b. The tolerance of the product by subjects assessments for any side effect such as Nausea, Stomach
upset, acute toxicity etc. observing during the study.
5. Rate of incidence of AE and SAEs - Recording any adverse or Serious adverse event (SAE) from day 01 to day 30 
30 days 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   14/02/2025 
Date of Study Completion (India) 26/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The relevance of this study is to evaluate the common yet neglected aspect of having a digestive system disorder and how it affects one’s quality of life. Pancreatic insufficiency, lactose intolerance, and irritable bowel syndrome (IBS), conditions that prevent the secretion of certain enzymes, result in symptoms such as heartburn, bloating, constipation, and diarrhea. Although these symptoms are commonly experienced, many people disregard timely intervention leading to residual discomfort in the gastrointestinal system. The current treatment options rely heavily on medication, which may deter individuals from using them due to the severe side effects. Additionally, these treatments are not suitable for extended use. Therefore, there are acceptable substitutes that are safer to use and can be taken for producing effective results that further improve digestive activity. A combination of enzyme and probiotic supplementation is one such technique that has the potential to improve digestion. This enhances nutrient absorption, relief from nervous system symptoms, and maintain an overall improvement of gastrointestinal issues. This study seeks to assess the effectiveness of DigeSEB Super PB formulation with the addition of digestive enzymes and probiotic supplements in relieving digestive symptoms among adults with mild to moderate digestive distress. By assessing the strength and efficacy of this formulation, the study contributes toward the development of safe and effective interventions that are not involving drugs targeting digestive health. This method would be advantageous for addressing issues of impaired digestion and exacerbating existing gastrointestinal disorders.
 
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