Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Intervention1: GUT RESET Capsules: Route of Administration: Oral
Once daily in the treatment period of 60 days.
Control Intervention1: Microcrystalline cellulose: Route of Administration: Oral
Once da
Sponsors
Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)
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, Pro-kinetics, 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 such as Iron deficiency anemia, 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. 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 |
|---|---|
| a. Establish the efficacy of GUT RESET Capsules in decreasing the GER symptoms on comparison with the placebo through GSAS. b. Justify the efficacy of GUT RESET Capsules in decreasing the dyspepsia symptoms on comparison with the placebo through 7-point Likert scale. c. Establish the safety and tolerability of GUT RESET Capsules in patients participating in the study.Timepoint: Day 1, Day 15, Day 30, Day 45, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. The number of treatment responders (Daily diary response of no symptoms on 6 days of the last 7 days of the study before follow-up with / without 1-day symptoms of heartburn or regurgitation). b. Reduction in frequency of occurrences of GER symptoms in patients receiving GUT RESET Capsules when compared with placebo assessed through GSAS. c. Significant reduction in heartburn and regurgitation symptoms towards the end of the study. d. Understand and establish the number of patients with complete resolution of heartburn. e. Change in Quality-of-life score (Global Assessment Questionnaire) Timepoint: Day 1, Day 15, Day 30, Day 45, Day 60 | — |
Countries
India
Contacts
Public ContactMeena Dalal
Rajalakshmi Hospital
Outcome results
None listed