| 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
|
|
|
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
|
|
|
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. |