Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
None listed
Sponsors
AVN Ayurveda Formulations Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex between the age group 18 to 60 years. 2. Patients with presence of any 2 of the following symptoms of GERD with frequency of at least 1 or more episode per 15 days, since the past 3 months: i. Heartburn ii. Regurgitation iii. Sour belching iv. Retrosternal chest pain 3. Patients with a GSRS (Gastrointestinal Symptom Rating Scale) score of 2 and above. 4. Patients with confirmed NERD/ERD with LA classification grades A and B in upper endoscopic examination. 5. Patients ready to abide by trial procedures and willing to give informed consent. (Los Angeles classification grade for erosive reflux esophagitis)
Exclusion criteria
Exclusion criteria: 1. Patients with ineligible for endoscopic procedure due to following hematological findings: i. Hemoglobin levels less than equal to 9 gm percent for females and less than equal to 11 gm percent for males ii. HIV I & II positive iii. Hepatitis C (HCV) positive iv. Hepatitis B (HBsAg) positive v. Random Blood Sugar Levels (BSL) more than 180 mg per dL vi. Bleeding Time (BT) less than 6 min and more than 1 min vii. Clotting Time (CT) less than 8 min and more than 2 min 2. Patients with Liver Function Test (LFT) levels less than 2.5 times and Renal Function Test (RFT) levels less than 1.5 times the upper normal limit. 3. Patients with abnormalities on Electrocardiogram (ECG). 4. Patients with abnormal findings on endoscopy viz. peptic ulcer or duodenal ulcer, Barrett s oesophagus, hiatal hernia etc. 5. Patients with history of usage of H2 blockers or PPIs in the last 30 days. 6. Patients with known history of previous surgery of gastrointestinal tract or ulcer. 7. Patients with known history of any severe cardiac disorders or severe hepatic, renal, or cerebrovascular disease, malignancy etc. 8. Patients with a history of hypersensitivity or allergy to study intervention drugs. 9. Patients with a history of participation in any clinical trial for the past 30 days. 10. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in the clinical symptoms of GERD. 2.Improvement in Quality of life. 3.Improvement in the esophageal mucosa with respect to hyperemia, discoloration, friability, haemorrhage, erosion etc. in case of erosions. 4.No changes in the safety parameters.Timepoint: Day 0, Day 8, Day 15, Day 30, Day 45, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in Quality of life 2. No changes in the safety parameters.Timepoint: Day 0, Day 8, Day 15, Day 30, Day 45, Day 60 | — |
Countries
India
Contacts
Public ContactMs Unnatii Ammale
Interactive Research School for Health Affairs Bharati Vidyapeeth (Deemed to be) University
Outcome results
None listed