Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of the uncomplicated symptomatic syndrome subgroup of GERD, (by the Montreal definition) with heartburn more than or equal to 2 times weekly for the past 3 months. . GERD-Q score of 8 or more . Clinically diagnosed patients of dyspepsia for at least 1 month with moderate-to-severe symptoms (score more than or equal to 3 on the 7-point Global Overal Symptoms [GOS] scale) Age group of 18 to 65 years All gender subjects Patients willing to take part in the study.
Exclusion criteria
Exclusion criteria: Patients with alarming symptoms such as unintentional weight loss, recurrent vomiting, difficulty in swallowing, painful swallowing, gastrointestinal bleeding, black stools, and anemia, history of serious gastrointestinal diseases including peptic ulcer, malignancy, and disorders of gut motility, previous endoscopic diagnosis of erosive gastroesophagitis or Barrett esophagus, prior gastric or esophageal surgery for the treatment of gastroesophageal reflux disease, history of gastrointestinal surgery within the past 30 days, patients with systemic illnesses such as cancer, epilepsy, kidney disease, cardiac disease, and pulmonary disease, history of angina pectoris, patients who have used more than 3 doses of histamine-2 receptor antagonists or proton pump inhibitors within the week before randomization, patients who have used anticholinergics, cholinergic drugs, spasmolytics, opiates, sucralfate, prokinetics, antibiotics, or bismuth compounds within 14 days of randomization, patients who have participated in an investigational drug or investigational device study within 30 days before the baseline visit, patients on concomitant psychotropic drugs, patients with hemoglobin less than 9 g/dl, total leukocyte count less than 3000/ l, platelet count less than 75000/ l, AST and ALT levels greater than 120 IU/L, or serum creatinine greater than 1.5 mg/dl, presence of occult blood in stool, history of alcohol consumption, patients who do not provide consent for the trial and follow-up, pregnant and lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-Form Leeds Dyspepsia Questionnaire GERD-Q (Gastroesophageal Reflux Disease Questionnaire) Timepoint: 0, 7th, 14th, 21st, and 28th Day. | — |
Secondary
| Measure | Time frame |
|---|---|
| GOS (Global Overall Symptoms) Scale Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaireTimepoint: 0, 7th, 14th, 21st, and 28th Day. | — |
Countries
India
Contacts
National Institute Of Unani Medicine