| CTRI Number |
CTRI/2025/08/092520 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Finding the Best Relief for Acid Reflux: A Study on Omeprazole, Vonoprazan, and Melatonin |
|
Scientific Title of Study
|
Comparative evaluation of the Efficacy of Omeprazole, Vonoprazan Combined with Melatonin and Vonoprazan monotherapy in the Management of Gastroesophageal Reflux Disease (GERD)- A Pilot Study. |
| Trial Acronym |
GEMS Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharmander Singh |
| Designation |
Assistant Professor |
| Affiliation |
Hakim Abdul Hameed Centenary Hospital |
| Address |
Room no: 92 OPD, Ground floor, Department Of Medicine, Hakim Abdul Hameed Centenary Hospital, Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
8860968415 |
| Fax |
|
| Email |
Dr.dharmander@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Nilanjan Saha |
| Designation |
Professor and HOD |
| Affiliation |
Jamia Hamdard |
| Address |
Room no: 354, Department of Translational and Clinical Research, Third Floor, School of Chemical and life sciences, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
9873013366 |
| Fax |
|
| Email |
nilanjan.saha@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Irtiqa Khan |
| Designation |
M.Sc. Student |
| Affiliation |
Jamia Hamdard |
| Address |
Room no: 356, Department of Translational and Clinical Research, Third Floor, School of Chemical and life sciences, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
9871825185 |
| Fax |
|
| Email |
irtiqakhan197@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi-110062, India |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi-110062, India
|
| Type of Sponsor |
Research institution |
|
|
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 Dharmander Singh |
Hakeem Abdul Hameed Centenary Hospital |
Room no: 92 OPD , Ground Floor, Department of Medicine, Hakeem Abdul Hameed Centenary Hospital, Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, 110062
South
DELHI |
8860968415
Dr.dharmander@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hamdard Institute of Medical Sciences and Research Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Oral tablet Melatonin 3mg once daily for two weeeks |
| Intervention |
Omeprazole |
Oral Tablet Omeprazole 20 mg once daily for 2 weeks |
| Intervention |
Vonoprazan |
Oral Tablet Vonoprazan 20mg once daily for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants who will be diagnosed with gastroesophageal reflux disease, confirmed by an FSSG score of less than 32, and who will be experiencing symptoms such as heartburn or regurgitation at least two or more days per week will be included.
Participants will either be prescribed omeprazole or vonoprazan and will be willing to take melatonin if required during the study.
All participants who will provide written informed consent and adhere to the study protocol. |
|
| ExclusionCriteria |
| Details |
Participants were excluded if they had a known hypersensitivity to omeprazole, vonoprazan, or melatonin, or if they had peptic or duodenal ulcers diagnosed through endoscopy. The exclusion criteria also included the concomitant use of medications known to interact significantly with the study drugs (e.g., fluvoxamine), the use of traditional medicines for GERD, presence of a hiatus hernia, refusal to follow dietary advice, or severe symptoms indicated by an FSSG score greater than 32. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| severity scores of heartburn and epigastric pain |
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient-reported quality of life and TEAE |
2 weeks and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 pilot study will aim to compare the efficacy and safety of three therapeutic approaches in the management of gastroesophageal reflux disease (GERD): omeprazole combined with melatonin, vonoprazan combined with melatonin, and vonoprazan monotherapy. Adult participants diagnosed with GERD will be enrolled and allocated into one of the three treatment arms. The study will evaluate improvements in symptom severity using the Frequency Scale for the Symptoms of GERD (FSSG) and assess changes in quality of life through validated scales. The incidence and severity of treatment-emergent adverse events will also be documented. This study will seek to determine the most effective and tolerable regimen for GERD symptom relief, with the goal of informing clinical decision-making in the Indian healthcare setting. |