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CTRI Number  CTRI/2025/01/079161 [Registered on: 21/01/2025] 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 evaluate the safety of GlucoSEB PB and its impact on metabolism and gut health in adults with diabetes 
Scientific Title of Study   A randomized, double blind, parallel, placebo-controlled study to evaluate metabolic health and gut microbiome in presence of GlucoSEB PB in diabetic adults as integrative care. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harsha Pamnani 
Designation  Consultant Endocrinologist 
Affiliation  Dr Harsha Pamnani 
Address  Ground floor, room no 2, h.no 41, Ashirwad medical, near GPO, opposite Hamidia Hospital, Bhopal

Bhopal
MADHYA PRADESH
462016
India 
Phone  9934647468  
Fax    
Email  drharshapamnani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhijit Rathi 
Designation  Principle Scientist 
Affiliation  Advanced Enzymes Technologies limited 
Address  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  2nd floor, plot no 1, Nevri Hills, Gufa Mandir road, Lalghati

Bhopal
MADHYA PRADESH
462030
India 
Phone  7032802286  
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
Advanced Enzymes Technologies Ltd. 5th floor, A wing, Sun Magnetica, LIC, Service Road, Louis Wadi, Thane West, Thane, Maharashtra, 400604 
 
Primary Sponsor  
Name  Advanced Enzymes Technologies Ltd. 
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 Harsha Pamnani  Dr Harsha Pamnani Clinic  Ground floor, room no 2, h.no 41, Ashirwad Medical, near GPO, opposite Hamidia Hospital, Bhopal
Bhopal
MADHYA PRADESH 
9934647468

drharshapamnani@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: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GlucoSEB PB  500mg, 2 capsules per meal (lunch and dinner), oral route of administration, swallow as a whole with water just before having meal, for 180 days 
Comparator Agent  Placebo  500mg, 2 capsules per meal (lunch and dinner), oral route of administration, swallow as a whole with water just before having meal, for 180 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects with less physical activity
2. BMI 18.5 to 35 Kg/m2
3. Subjects with recent HbA1c reports within 2 weeks can be considered as screening value for
participation in the study.
4. Subjects taking stable medicine dose for past 3 months
5. Subjects who occasionally consume sweets
6. Subjects with fasting blood sugar level ≥130 mg/dL and HbA1c 7.0 to 11.0%
7. Subjects must have a history of diabetes for more than 1 year and have been on a stable medication regimen for at least the past 9 months
8. 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. Type I diabetic patients
4. HbA1c less than 7.0 and greater than 11.0%
5. Diabetes medication (DPP4 inhibitors, Acarbose, Voglibose, Repaglinide, GLP1 receptor agonists
(GLP1RA), and Insulin)
6. Patients with major chronic complications (including but not limited to) autoimmune disease,
inflammation, etc.
7. Organic insufficiency (cardiac, hepatic, renal, respiratory)
8. Use of food supplements specifically containing fibers or polysaccharides
9. Chronic smoking and alcohol intake
10. Allergy to the ingredients in the test product.
11. History of any surgery in the past 3 months.
12. Subject currently taking or has in the past 30 days used GI related probiotics or prebiotics or any 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 
Change in HbA1c (assessment on Day -1 to Day -7, Day 90 and Day 180)  180 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 & Day 180).
2. Change in fasting insulin (assessment on Day 1, Day 90 & Day 180)
3. Calculate- HOMA-IR score- fasting insulin (μIU per ml) X fasting glucose (mmol per L) divided by 22.5
a. beta-cell function (HOMA-beta)- [20 X Fasting insulin (microIU/mL)] divided by [Fasting glucose (mmol per L) – 3.5]
b. Disposition index (DI)- DI is equal to 450 divided by [(FPG)2 – (FPG X 3.5)]
c. Quantitative insulin sensitivity check index (QUICKI)- QUICKI is equal to 1 divided by [log (fasting insulin microIU per mL) plus log
(fasting plasma glucose mg per dL)]
4. Change in Lipid profile (assessment on Day 1, Day 90 & Day 180)- Quantification of TC, TG, LDL, HDL, VLDL 
180 days 
5. Change in anthropometric parameters (assessment on Day -1 to Day -7, Day 1, Day 90 & Day 180) - Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR), Body fat percentage
(BFP).
6. Assess the peak plasma levels of Glucagon Like peptide-1 (GLP-1) at day 1 & day 180.
7. Change in Gut microbiome (assessment on Day 1 & Day 180) - Microbiota analysis of subjects from test & placebo arm (randomly selected 5 subjects from each arm on Day 1).
8. Questionnaire based assessment - Hunger & satiety scale, 36-Item Short Form Survey Instrument (SF-36) on Day 1, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 105, Day 120, Day 135, Day 150, Day 165, & Day 180.
9. Liver & Renal safety (assessment on Day 1, Day 90 & Day 180)- Check levels of AST, ALT, hs CRP, BUN, total albumin & globulin. 
180 days 
10. CBC analysis on Day 1, Day 90 & Day 180, & vital sign measurement (assessment on every visit).
11. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or
paper record)
12. Tolerability- The tolerance of the product by participants assessments for any side effect such as
Nausea, Vomiting, Bloating, Abdominal cramps & heartburn experienced during the study. The tolerability will be evaluated by the intensity of each individual symptom on a validated 5-point Likert
scale (0-no problem, 1-mild problem, 2-moderate problem, 3-severe problem & 4-very severe problem)
13. Rate of incidence of AE & SAEs- Recording any adverse (AE) or serious adverse event (SAE) from
Day 1 to Day 180 
180 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 2 
Date of First Enrollment (India)   03/02/2025 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  
T2DM can be a long-term condition that requires extended blood sugar management: the combined approaches such as pharmacological, physical and, in recent years, therapeutic interventions directed at the microbiome are the most effective in managing it (Diagnosis and Classification of Diabetes Mellitus, 2013). While standard formulations which include insulin, metformin and SGLT2 inhibitors assist patients to manage their blood glucose levels, they rarely come without a fair share of side effects such as hypoglycemia, weight gain or gastrointestinal problems (Wilcox et al., 2020). They do not, however, resolve the underlying problems that lead to insulin resistance and β-cell dysfunction. For this reason, there has been a growing need to look for new and safer, and combined therapies that help not only control hyperglycemia but also treat underlying conditions, the imbalanced metabolic state (Cerf, 2013).The enzyme blend GlucoSEB PB can be a part of diabetic care regimen. The enzymes modulate carbohydrate metabolism while probiotics support in improving gut health. Numerous studies have reported that the gut microflora is closely related to body metabolism. An imbalance of intestinal microbiota, or dysbiosis, is one characteristic of T2DM that leads to metabolic dysregulation by causing insulin resistance, systemic inflammation and increased gut permeability (Hou et al., 2022; Wu et al., 2023; Xia et al., 2021). GlucoSEB PB consists of components that have gut microbiome targeted mechanisms primarily focused on enhancing metabolic parameters in patients with diabetes rather than solely targeting dysglycemia. The aim of evaluating GlucoSEB PB is described as follows:  Metabolic Health: The enzyme blend is useful in decreasing the glycemic index of consumed carbohydrates by controlling the free glucose into the bloodstream, thus lowering blood glucose levels after a meal. This might have special significance in avoiding glucose toxicity which is one of the factors that lead to insulin resistance. The manufacture of prebiotic fibers also helps in metabolic health by altering the gut microbiota which may increase insulin sensitivity and decrease systemic inflammation levels.  Gut Microbiome Modulation: Since there is a wealth of data associating gut dysbiosis and T2DM; promoting good gut bacteria through GlucoSEB PB is of particular interest. There are studies that support the use of Probiotics as adjunct therapy for blood sugar control and those that reduce inflammation and improve metabolic disease. Since GlucoSEB PB may promote a healthier microbiome, it may also have a wider effect on metabolic health other than dysglycemia. GlucoSEB PB treatment combines the benefits of targeting metabolic and gut health to diminish the ill effects caused due to diabetes. GlucoSEB PB is an advanced therapy that promises new avenues aimed at diabetes management.
 
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