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.
- Conditions
- Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
- Registration Number
- CTRI/2023/03/050245
- Lead Sponsor
- Healing Hands & Herbs Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compared the change in Reflux Disease Questionnaire (RDQ) Score for GERD (Heartburn+ regurgitation)Timepoint: Upto 2 weeks
- Secondary Outcome Measures
Name Time Method Compared the change in RDQ Scores for individual heartburn, regurgitation and acidity.Timepoint: Upto 2 weeks