Indigestion AcidPhase 3NCT07140341
A Clinical Study to Assess the Effectiveness of ENO Lime in Participants With Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, and Associated Nausea)
A Phase 3 study testing ENO Lime in people with Indigestion Acid and Indigestion, run by HALEON at 3 sites in India.
Trial summary
The primary purpose of this study is to assess the efficacy of ENO Lime (fruit salt) in participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) at 15-minutes after administration of dose. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Indigestion Acid, Indigestion, Nausea
- What is being tested?
- ENO Lime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesIndia
- Study dates
- 20 Aug 2025to 6 Sep 2025
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female participants with age 18-60 years (both inclusive).
- Participants newly experiencing symptom/s of Ajeerna vyadhi for not more than 10 days.
- Participants with at least one symptom of Ajeerna vyadhi (according to Charak Samhita and Madhav Nidan) that is acidity (heartburn), acid indigestion (epigastric pain), indigestion (abdominal discomfort), or associated nausea.
- Participants with VAS score greater than or equal to (>=) 40-mm and less than or equal to (<=) 80-mm Ajeerna vyadhi (acidity, acid indigestion, indigestion, or associated nausea) at the Baseline visit.
- Participants are able to read, understand, and provide written informed consent.
- Participants who can understand and complete the VAS.
Who cannot join
- Participants with chronic and recurrent cases of Ajeerna vyadhi.
- Participants with Updrava of Ajeerna vyadhi (Complications of indigestion).
- Pregnant women (self-reported) and breastfeeding females or females intending to become pregnant during the study.
- Participant had surgery in the last 14 days.
- Participant has been exposed to barium meal 3 days before screening.
- Participants already on any indigestion or acidity medication.
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- Participants taking any medicinal/over-the-counter (OTC)/ herbal medicine from the past 3 days.
- Participants on medications that could interact with ENO Lime (example, antacids, proton pump inhibitors, or H2 blockers) as per the judgment of the Investigator/designee.
- Participants with known hypersensitivity to any of the components of ENO Lime (Svarjiksara [Shudh], Nimbu Rasa [Citrus limon, Fruit Juice Powder]).
- Participants with a history of gastrointestinal (GI) disorders such as peptic ulcers, gastritis, irritable bowel syndrome (IBS), or other serious GI diseases.
- Participants with serious renal, hepatic, or cardiovascular diseases.
- Participants on a sodium restricted diet example, those suffering from hypertension or congestive heart failure.
- Participants who have participated in another clinical trial within the last 30 days.
- Any participant who, in the opinion of the investigator, should not participate in the study.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Shri Krishna Super Speciality Institute of Ayurveda
New Delhi, 110058
Lifepoint Hospital
Pune, Maharashtra, 411057
Ojas Hospital
Pune, Maharashtra, 412101
About this study
Official title: A Multi-center, Open Label, Single Arm, Interventional Clinical Study to Assess the Efficacy of ENO Lime in Patients With Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, and Associated Nausea)
The primary purpose of this study is to assess the efficacy of ENO Lime (fruit salt) in participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) at 15-minutes after administration of dose. 'Ajeerna vyadhi' is defined as a state of incomplete digestion and metabolism caused due to deranged action of Jatharagni (digestive fire), which leads to the formation of an unprocessed or under-processed state of ingested food termed as Ajeerna.
Read the detailed description
This will be an open label, single arm, interventional clinical study to evaluate the efficacy and safety of ENO Lime in adult participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea). The study will be conducted at three sites in India and approximately 40 participants will be enrolled. At baseline, the participants will record the severity of symptoms of Ajeerna vyadhi using the visual analogue scale (VAS) scoring before administering the ENO Lime. As per recommendation, the participants will consume the dose of the ENO Lime on-site and will record any changes in the severity of symptoms of Ajeerna vyadhi using VAS scoring at 2-minutes, 15-minutes, 1-hour, 2-hour post-dose. Participants will be permitted to take the second dose of the ENO Lime (only if required) after 2 hours of the first dose. In such cases, participants will be instructed to record symptoms of Ajeerna vyadhi again using the VAS scoring before taking the second dose (at 0 minutes) and then at 2-minutes, 15-minutes, 1-hour, and 2-hours post-second dose.
- Conditions
- Indigestion Acid, Indigestion, Nausea
- Being tested
- ENO Lime
- Medical subject headings
- Dyspepsia, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENO LimeDrug
A fruit salt (sachet of 5-gram powder) with lime flavor containing Svarjiksara (Shudh) 2220 milligram (mg) and Nimbu Rasa (Citrus limon, Fruit Juice Powder) 150 mg
| Study group | Role | What they receive |
|---|---|---|
| ENO Lime | Experimental | Participants will be instructed to take 1 sachet of ENO Lime powder with approximately 150 milliliters (ml) of normal water as a single dose. Participants will be advised to repeat the dose after 2-hours, if necessary (Maximum 2 sachet per 24-hours). Participants will be followed up for 24-hours. Receives: Drug: ENO Lime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 15 Minutes of Taking ENO Lime
The severity of symptoms of Ajeerna vyadhi will be recorded using VAS scoring. Participants will record a score with a mark at one point along the length of a 100-millimeter (mm) line, where the lowest score 0-mm indicates 'no discomfort' and highest score 100-mm indicates 'worst possible discomfort'. Higher the score, more severe will be the symptoms. Change from baseline will be calculated by subtracting baseline value from the value at 15-minutes.
Measured: Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1
Secondary outcomes (1)
Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 2-Minutes, 1-Hour, and 2-Hours of Taking ENO Lime
The severity of symptoms of Ajeerna vyadhi will be recorded using VAS scoring. Participants will record a score with a mark at one point along the length of a 100-mm line, where the lowest score 0-mm indicates 'no discomfort' and highest score 100-mm indicates 'worst possible discomfort'. Higher the score, more severe will be the symptoms. Change from baseline will be calculated by subtracting baseline value from the values at the indicated timepoints.
Measured: Baseline (0 minutes pre-dose) and 2-minutes, 1-hour, 2-hours post-dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start20 Aug 2025
- Primary completion6 Sep 2025
- Study completion6 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indigestion AcidStudies of the same condition, open and under way.
- More trials run by HALEONThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140341
- Sponsor's protocol ID
- 300269
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label, Single Arm, Interventional Clinical Study to Assess the Efficacy of ENO Lime in Patients With Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, and Associated Nausea)
- ClinicalTrials.gov ID
- NCT07140341
- Acronym / sponsor ID
- 300269
- Conditions
- Indigestion Acid, Indigestion, Nausea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 6 Sep 2025 (actual)
- Study completion
- 6 Sep 2025 (actual)
- First posted
- 24 Aug 2025 (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.
The primary purpose of this study is to assess the efficacy of ENO Lime (fruit salt) in participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) at 15-minutes after administration of dose. 'Ajeerna vyadhi' is defined as a state of incomplete digestion and metabolism caused due to deranged action of Jatharagni (digestive fire), which leads to the formation of an unprocessed or under-processed state of ingested food termed as Ajeerna.
Detailed description
This will be an open label, single arm, interventional clinical study to evaluate the efficacy and safety of ENO Lime in adult participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea). The study will be conducted at three sites in India and approximately 40 participants will be enrolled. At baseline, the participants will record the severity of symptoms of Ajeerna vyadhi using the visual analogue scale (VAS) scoring before administering the ENO Lime. As per recommendation, the participants will consume the dose of the ENO Lime on-site and will record any changes in the severity of symptoms of Ajeerna vyadhi using VAS scoring at 2-minutes, 15-minutes, 1-hour, 2-hour post-dose. Participants will be permitted to take the second dose of the ENO Lime (only if required) after 2 hours of the first dose. In such cases, participants will be instructed to record symptoms of Ajeerna vyadhi again using the VAS scoring before taking the second dose (at 0 minutes) and then at 2-minutes, 15-minutes, 1-hour, and 2-hours post-second dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENO Lime | Experimental | Drug: ENO LimeParticipants will be instructed to take 1 sachet of ENO Lime powder with approximately 150 milliliters (ml) of normal water as a single dose. Participants will be advised to repeat the dose after 2-hours, if necessary (Maximum 2 sachet per 24-hours). Participants will be followed up for 24-hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female participants with age 18-60 years (both inclusive).
- Participants newly experiencing symptom/s of Ajeerna vyadhi for not more than 10 days.
- Participants with at least one symptom of Ajeerna vyadhi (according to Charak Samhita and Madhav Nidan) that is acidity (heartburn), acid indigestion (epigastric pain), indigestion (abdominal discomfort), or associated nausea.
- Participants with VAS score greater than or equal to (>=) 40-mm and less than or equal to (<=) 80-mm Ajeerna vyadhi (acidity, acid indigestion, indigestion, or associated nausea) at the Baseline visit.
- Participants are able to read, understand, and provide written informed consent.
Key exclusion criteria (14 listed)
- Participants with chronic and recurrent cases of Ajeerna vyadhi.
- Participants with Updrava of Ajeerna vyadhi (Complications of indigestion).
- Pregnant women (self-reported) and breastfeeding females or females intending to become pregnant during the study.
- Participant had surgery in the last 14 days.
- Participant has been exposed to barium meal 3 days before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENO LimeA fruit salt (sachet of 5-gram powder) with lime flavor containing Svarjiksara (Shudh) 2220 milligram (mg) and Nimbu Rasa (Citrus limon, Fruit Juice Powder) 150 mg | Drug | ENO Lime |
Primary outcome
Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 15 Minutes of Taking ENO Lime
Time frame: Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1
The severity of symptoms of Ajeerna vyadhi will be recorded using VAS scoring. Participants will record a score with a mark at one point along the length of a 100-millimeter (mm) line, where the lowest score 0-mm indicates 'no discomfort' and highest score 100-mm indicates 'worst possible discomfort'. Higher the score, more severe will be the symptoms. Change from baseline will be calculated by subtracting baseline value from the value at 15-minutes.
1 secondary outcome
Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 2-Minutes, 1-Hour, and 2-Hours of Taking ENO Lime
Time frame: Baseline (0 minutes pre-dose) and 2-minutes, 1-hour, 2-hours post-dose on Day 1
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 17 Sep 2025.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ENO Lime in people with Indigestion Acid and Indigestion, run by HALEON at 3 sites 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 6 inclusion and 14 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 15 Minutes of Taking ENO Lime (time frame: Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1). 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 17 Sep 2025.