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CTRI Number  CTRI/2026/03/105636 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 07/03/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A randomized clinical study to compare the effectiveness and safety of two antacid combination treatments for relief of acute indigestion symptoms in adults. 
Scientific Title of Study   A prospective, randomized, assessor-blinded, two arm, comparative, real-world clinical study to evaluate the effectiveness and safety of a fixed-dose combination (FDC) of magaldrate, activated dimethicone, oxetacaine, and dicyclomine compared with FDC of magaldrate, simethicone, and oxetacaine for symptomatic relief in adult patients with acute gastrointestinal dyspeptic symptoms. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IN-26-01 Version 01 Dated 28 JAN 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayesh Sanmukhani 
Designation  Head – Medical Services 
Affiliation  Clinexcel Research 
Address  297/301, SoBo Center, South Bopal, ahmedabad. Ahmadabad GUJARAT 380058 India

Ahmadabad
GUJARAT
380058
India 
Phone  07600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Anil Trailokya 
Designation  Sr. GM Medical Services 
Affiliation  Indoco House, 166 CST Road, Santacruz (E) 
Address  Indoco House, 166 CST Road, Santacruz (E) Mumbai MAHARASHTRA 400098 India

Mumbai
MAHARASHTRA
400098
India 
Phone  8080042460  
Fax    
Email  abhijit.trailokya@indoco.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhijit Anil Trailokya 
Designation  Sr. GM Medical Services 
Affiliation  Indoco House, 166 CST Road, Santacruz (E) 
Address  Indoco House, 166 CST Road, Santacruz (E) Mumbai MAHARASHTRA 400098 India


MAHARASHTRA
400098
India 
Phone  8080042460  
Fax    
Email  abhijit.trailokya@indoco.com  
 
Source of Monetary or Material Support  
Indoco Remedies Limited,Indoco House, 166 CST Road, Santacruz(E), Mumbai 400 098, India. 
 
Primary Sponsor  
Name  Indoco Remedies Limited 
Address  Indoco House, 166 CST Road, Santacruz(E), Mumbai 400 098, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chintan Patel  Aatman Hospital  Basement, Clinical Research Department,5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal - 380058 India
Ahmadabad
GUJARAT 		 9825182251

drchintan.cr@gmail.com  
Dr Bakulesh A Madhu   Harshil Medical Nursing Home   Room no 05, 1st floor Clinical Research Department, 19, Asha Society, Near Verai Mata Temple, near Isanpur bus stop,Isanpur-bhairavnath road, Isanpur,382443
Ahmadabad
GUJARAT 		 9824045708

drbakuleshmadhucr@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACEAS Independent Ethics Committee  Approved 
Harshil Research Institute Ethics Committee Harshil Medical Nursing Home  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  
Type  Name  Details 
Intervention  Formulation A-FDC containing Magaldrate 480 mg, Activated Dimethicone 50 mg, Oxetacaine 10 mg, and Dicyclomine 10 mg per 5 mL.  Fixed Dose Combination oral suspension containing Magaldrate 480 mg, Activated Dimethicone 50 mg, Oxetacaine 10 mg, and Dicyclomine 10 mg per 5 mL. Administered orally as 5 mL three times daily (TID), preferably after meals, for 5 days. 
Comparator Agent  Formulation B-FDC containing Magaldrate 540 mg, Simethicone 50 mg, and Oxetacaine 10 mg per 5 mL.  Fixed Dose Combination (FDC) oral suspension containing Magaldrate 540 mg, Simethicone 50 mg, and Oxetacaine 10 mg per 5 mL. The study medication will be administered orally as 5 mL three times daily (TID), preferably after meals, for a total duration of 5 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either gender between 18 to 60 years of age, both inclusive.
2.Patients presenting with acute gastrointestinal dyspeptic symptoms such as heartburn,
regurgitation, epigastric pain or burning, bloating, belching and abdominal cramps
for at least 48 hours prior to screening and enrollment.
3.Patients willing to provide written informed consent and comply with the protocol
requirements.
 
 
ExclusionCriteria 
Details  1. Patients with known or suspected peptic ulcer disease with alarm features such as
unexplained weight loss, melena, hematemesis, gastrointestinal bleeding, or history of
gastrointestinal surgery affecting motility.
2. Patients with known hypersensitivity to any component of Test or Reference product.
3. Pregnant or lactating females or female patients of childbearing potential unwilling to
undergo pregnancy testing or use effective contraception, as applicable.
4. Use of other antacids, proton pump inhibitors, H2 blockers, or antispasmodics
within 48 hours prior to randomization.
5. Participation in another clinical trial within 3 months prior to screening.
6. Patients with any severe concomitant illness that in the investigators opinion would
interfere with study participation or outcome assessment.
7. Any other reason for which the investigator feels that the patient should not participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of patients achieving clinically meaningful symptom relief at Day 1, defined
as at least a 50% reduction from baseline in the Patient Global Symptom Score (PGSS). 		 At Day 1 (Visit2)
 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first meaningful symptom relief, as reported by the patient, following
administration of the first dose of study medication 		 At Day 1(Visit2) 
Mean change in PGSS from baseline to Day 3 and Day 5 in the two treatment groups  From Day 0 (Baseline) to Day 3 (Visit3) and Day 5(End of study) 
Proportion of patients with at least a 1-point improvement from baseline in each
individual symptom score (heartburn, regurgitation, epigastric pain/burning, bloating,
belching, and abdominal cramps, as applicable). 		 At Day 3(Visit3) and Day 5(End of study) 
Number of doses of rescue medication used during the 5-day study period.  Up to Day 5(Baseline to End of study) 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   19/03/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This will be a prospective, randomized, assessor-blinded, two-arm, comparative, real-world, post-marketing clinical study to evaluate the effectiveness and safety of Formulation A (fixeddose combination oral suspension of magaldrate, activated dimethicone, oxetacaine, and dicyclomine) as compared to Formulation B (fixed-dose combination oral suspension of magaldrate, simethicone, and oxetacaine) for symptomatic relief in adult patients with acute gastrointestinal dyspeptic symptoms. Study assessments will be conducted through a telephonic follow-ups and on-site visits. Following randomization on Day 0, patients will remain at the study site for assessment of time to first meaningful symptom relief after administration of the first dose of study medication. Patients will subsequently be followed up via telephonic assessments at 24 hours (Day 1) and on Day 3, and will attend an on-site end-of-study visit on Day 5.  
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