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A Clinical Trial to study the Safety And Efficacy of ACIDEEM Plus Tablet Vs Pantoprazole 40mg tablet for Reflux Disease, Regurgitation and Heartburn, Acidity in Indian adults for decreasing upper Gastrointestinal symptoms.

Prospective, Open label, observational, Multicenter study for evaluation of efficacy and safety of ACIDEEM Plus Tablet vs Pantoprazole 40mg for Reflux disease, regurgitation and heartburn, acidity in Indian adults for decreasing upper gastrointestinal symptoms.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050245
Enrollment
100
Registered
2023-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis

Interventions

None listed

Sponsors

Healing Hands & Herbs Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years of age. 2.Patient with diagnosis of uncomplicated symptomatic GERD. 3.Patient/Parent/legal guardian willing to give a written informed consent/parental consent/assent form. 4.Able to/Willing to strictly adhere to investigator’s prescription.

Exclusion criteria

Exclusion criteria: 1.Individuals were excluded if they had taken any medications which might interfere with the action of the study medications prior to the start of the study or during the study. 2.Patient having a clinical history or symptom profile suggestive of complicated GERD, other GI diseases (including Barrett’s oesophagus, acute peptic ulcer, or indication for Helicobacter pylori eradication therapy) or any severe diseases of other major body systems. 3.Patient having any existing conditions that might compromise their safety or participation in the study.

Design outcomes

Primary

MeasureTime frame
Compared the change in Reflux Disease Questionnaire (RDQ) Score for GERD (Heartburn+ regurgitation)Timepoint: Upto 2 weeks

Secondary

MeasureTime frame
Compared the change in RDQ Scores for individual heartburn, regurgitation and acidity.Timepoint: Upto 2 weeks

Countries

India

Contacts

Public ContactDrAshwin Porwal

Healing hands clinic.

drashwinporwal@healinghandsclinic.co.in9822347770

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026