Health Condition 1: null- Gastroesophageal reflux disease (GERD)
Conditions
Interventions
Intervention1: Dietary Fiber: It is a sachet of 5gms. It is to be dissolved in a glass of water and to be taken with meals. Dose: 5 grams twice daily for duration of 8 weeks.(Subject will be instructe
Sponsors
Mr Ajay Nilawar
Eligibility
Inclusion criteria
Inclusion criteria: Males and females 18 -65 years of age (both inclusive). • Patient clinically diagnosed with typical GERD symptoms as heartburn or regurgitation. • Patient who does not have relief with diet and lifestyle management or not responding to medical therapy. • Patient must be able to understand and complete questionnaires. • Patient must be willing to or likely to comply with all study requirements. • Patient must be able and willing to provide written informed consent. • Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
Exclusion criteria
Exclusion criteria: Complications of gastroesophageal reflux disease including esophageal stricture, Barrettâ??s esophagus or adenocarcinoma of the esophagus, or extraesophageal manifestations of reflux disease (pulmonary or laryngeal disease due to acid reflux) which in the opinion of the Investigator may preclude trial participation. • Diagnosis of any other clinically significant medical condition or serious gastrointestinal disorder which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation. • Patients with medical history of surgery of esophagus, stomach or duodenum. • Suffering from any condition which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. subacute obstruction. • Current use of medication which in opinion of the Investigator may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation. • Abuse of drugs or alcohol. • Known case of sensitivity to Gluten or Coeliac disease. • Pregnant or lactating women. • Currently participating or had participated in any other interventional study in last 1 month prior to screening. • Patients who are unlikely to comply with protocol requirements (e.g. noncooperative behavior, illiterate, inability to attend study visits required by the protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in symptom frequency and intensity using Gastroesophageal reflux disease symptom assessment scale (GSAS).Timepoint: Screening and week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life using GERD- Health related quality of life questionnaire (GERD-HRQOL).Timepoint: Screening, week 2 | — |
Countries
India
Contacts
Public ContactDr Almas Pathan
Jehangir Clinical Development Centre Pvt Ltd
Outcome results
None listed