GERDNCT07919522
The Prospective Observational Study Evaluating the Clinical Profile and Correlation of Subjective and Objective Parameters of GERD in a Tertiary Care Hospital : An Indian Perspective
An observational study of GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
This prospective, single-center study at AIG Hospitals, Hyderabad, aims to establish normal 24-hour ambulatory esophageal pH-impedance values, including acid exposure time (AET), in 50 healthy Indian adults. Read more about this study
- Who is it for?
- Ages 18 to 50 months
- Conditions the study is for
- GERD
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2026to 8 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 months
- All sexes
- No healthy volunteers
- Child
Study population: This study will include adults aged 18-50 years with GERD symptoms
Who may be able to join
- Age ≥18 years.
- Symptoms of GERD (heartburn, regurgitation, chest pain) diagnosed using:
- Clinical symptoms based on validated questionnaires. Endoscopic findings (e.g., esophagitis, Barrett's esophagus). Provide written informed consent.
Who cannot join
- Pregnant women or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
This prospective, single-center study at AIG Hospitals, Hyderabad, aims to establish normal 24-hour ambulatory esophageal pH-impedance values, including acid exposure time (AET), in 50 healthy Indian adults. Current Western diagnostic cut-offs may not be applicable to the Indian population, where normal AET is likely lower. Healthy volunteers aged 18-50 with no GI symptoms or systemic diseases will undergo baseline evaluations, high-resolution manometry, and 24-hour pH-impedance monitoring while maintaining regular activities. The study will assess how diet, body position, and sleep affect reflux, with statistical analysis to determine normative values for improved GERD diagnosis in India.
- Conditions
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| This study will include a cohort of adults aged 18-50 years with GERD symptoms | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate the subjective (GERD HRQL scores) and objective (Endoscopy, Esophageal manometry and 24-hour pH- impedance monitoring) parameters of GERD
Measured: 12 months
Secondary outcomes (1)
To develop predective models for forecasting manometric and pH findings
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jan 2026
- Primary completion1 Aug 2026
- Study completion8 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919522
- Sponsor's protocol ID
- GERDCR-01
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Observational Study Evaluating the Clinical Profile and Correlation of Subjective and Objective Parameters of GERD in a Tertiary Care Hospital : An Indian Perspective
- ClinicalTrials.gov ID
- NCT07919522
- Acronym / sponsor ID
- GERDCR-01
- Conditions
- GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 8 Aug 2026 (actual)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-center study at AIG Hospitals, Hyderabad, aims to establish normal 24-hour ambulatory esophageal pH-impedance values, including acid exposure time (AET), in 50 healthy Indian adults. Current Western diagnostic cut-offs may not be applicable to the Indian population, where normal AET is likely lower. Healthy volunteers aged 18-50 with no GI symptoms or systemic diseases will undergo baseline evaluations, high-resolution manometry, and 24-hour pH-impedance monitoring while maintaining regular activities. The study will assess how diet, body position, and sleep affect reflux, with statistical analysis to determine normative values for improved GERD diagnosis in India.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This study will include a cohort of adults aged 18-50 years with GERD symptoms | – | – |
Who may qualify
- Ages
- 18 to 50 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will include adults aged 18-50 years with GERD symptoms
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Clinical symptoms based on validated questionnaires. Endoscopic findings (e.g., esophagitis, Barrett's esophagus). Provide written informed consent.
Key exclusion criteria (1 listed)
- Pregnant women or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To correlate the subjective (GERD HRQL scores) and objective (Endoscopy, Esophageal manometry and 24-hour pH- impedance monitoring) parameters of GERD
Time frame: 12 months
1 secondary outcome
To develop predective models for forecasting manometric and pH findings
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate the subjective (GERD HRQL scores) and objective (Endoscopy, Esophageal manometry and 24-hour pH- impedance monitoring) parameters of GERD (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 5 Nov 2026.