Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Intervention1: GutGard: GutGard 75mg capsule twice daily after food intake for 4 weeks
Control Intervention1: Placebo: Matching identical placebo twice daily after food intake for 4 weeks
Sponsors
Natural Remedies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Apparently healthy adults of any gender 18 - 60 years of age, willing to provide consent affected by symptoms of GER 2. History of GER-related symptoms for at least 1 month prior to study inclusion and otherwise healthy 3. Not participated in any other interventional trials in the last 1 month before trial recruitment 4. Willing to discontinue medications like H2 Receptor antagonists, Antacids, Prokinetics and supplements that have been prescribed for the GER related symptoms and not on any of these agents in the last 10 days before randomization 5. Presence of symptoms of at least 2 days in the week preceding randomization
Exclusion criteria
Exclusion criteria: 1. Presence of any of the following red flag symptoms of dyspepsia – Iron deficiency anaemia, dysphagia, weight loss, persistent vomiting, GI bleed, epigastric mass 2. Women of reproductive age who are pregnant / lactating / not willing for adequate contraception 3. History of allergy to any medications including alternate system of medications 4. History of uncontrolled diabetes (Random Blood Sugar > 200mg%) 5. Inability to follow-the protocol or expressed inability to complete all follow-ups 6. Abnormalities in the liver function tests (defined as total bilirubin >1mg% or SGOT / SGPT > 3 times the upper limit of normal) 7. Abnormal renal function test (Creatinine > 1.4mg%) 8. Congestive cardiac failure and other medical conditions which the investigator feels will affect the pharmacokinetic parameters of the study drug 9. History of erosive esophagitis, Barrett’s esophagus, tumoral pathologies, atypical pathology without heartburn and ulcer 10. Severe disease that affect activities of daily living as assessed by GERD – HRQoL scale, where the score for heartburn and regurgitation > 3 11. Presence of HIV, HbsAG or HCV positive and any other medical/ surgical condition the investigator feels may cause harm to the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Among patients with Gastro-esophageal Reflux (GER) related symptoms predominantly heartburn, to assess the efficacy of GutGard 150mg (75mg twice daily) in comparison to those receiving placebo over a 4-week period using 1. GERD Health-Related Quality of Life (GERD-HRQoL) on D28 . 2. Symptoms severity score as assessed by Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) on days 7, 14, 28 and 35Timepoint: Days 7, 14, 28 & 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency & level of severity of individual GER related symptoms as assessed by GSASTimepoint: Days 7, 14, 28, 35;Medication AdherenceTimepoint: Days 28;Number of rescue medications usedTimepoint: Day 14, 28 & 35;Change in Quality of life score (Global Assessment Questionnaire)Timepoint: Day 28;Proportion of participants with rebound effects (requirement of at least 1 day of rescue medication or = 2 days of mild symptoms)Timepoint: Day 35;Change in pH at lower oesophagus and lower esophageal sphincter pressure in 10% of participantsTimepoint: Anytime between days 26-28;Mean percent change in gastric emptying as measured by solid meal scintigraphyTimepoint: Day 28;Mean Percent Change in gastric emptying as assessed by liquid meal scintigraphy in those with abnormal solid meal scintigraphyTimepoint: Day 28;Proportion of ADRsTimepoint: Days 7, 14, 21 & 28 | — |
Countries
India
Contacts
Public ContactDr Jeffrey Pradeep raj
Seth GSMC & KEM Hospital
Outcome results
None listed