Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
None listed
Sponsors
Ethniq Ayush Exports LLP
Eligibility
Inclusion criteria
Inclusion criteria: Age and Sex: Apparently healthy Male and Female participants aged 18 to 65 years. Diagnosis: Subjects diagnosed with gastroesophageal reflux disease (GERD) as per the Montreal definition and classification. Experiencing moderate to severe bloating at least two times a week preceding randomization. Symptom Duration: Persistent GERD and bloating symptoms for at least three months prior to screening. Severity: A GERD Symptom Assessment Scale (GSAS) score of = 3. A bloating severity score of = 4 on a 10-point visual analog scale (VAS). BMI: Body Mass Index (BMI) between 18.5 and 35 kg/m². General Health Status: Generally healthy individuals without any significant uncontrolled medical condition (e.g., cardiovascular disease, diabetes mellitus, liver or kidney disease). Reproductive Status: Women of childbearing potential must have a negative pregnancy test at screening and agree to use adequate contraception during the study. Consent and Compliance: Willing and able to provide written informed consent to participate in the study. Willing to comply with all study procedures, including taking the supplement and attending follow-up visits. Medication and Supplement uses: 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.
Exclusion criteria
Exclusion criteria: Severe GERD Complications History of severe GERD complications, including esophageal stricture, Barretts esophagus, or esophageal cancer. Gastrointestinal Surgery History of gastrointestinal surgery within the past six months. Other GI Disorders Diagnosis of other significant gastrointestinal disorders, including Crohns disease, ulcerative colitis, celiac disease, or irritable bowel syndrome. Medication Use Use of proton pump inhibitors, H2 receptor antagonists, or other medications for GERD or bloating within two weeks prior to screening. Use of antibiotics, probiotics, or other gastrointestinal medications within one month prior to screening. Pregnancy or Lactation Pregnant or breastfeeding women. Substance Abuse History of alcohol or drug abuse within the past year. Significant Medical Conditions Presence of significant uncontrolled medical conditions, including but not limited to cardiovascular, respiratory, renal, hepatic, hematological, or psychiatric disorders. Infections Active infection requiring systemic antibiotic or antiviral therapy. Allergies and Sensitivities Known allergy or sensitivity to any ingredient in the test supplement or reference product. Participation in Other Studies Participation in another clinical trial within the past three months.Concurrent participation in another clinical trial that could interfere with this studys outcomes. Compliance and Consent Inability or unwillingness to provide written informed consent. Inability or unwillingness to comply with all study procedures and attend follow-up visits. Any condition or factor that, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with the participants ability to comply with study requirements.Major psychiatric disorders that could interfere with study compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in GERD Symptoms by GERD Symptom Assessment Scale (GSAS)Timepoint: Day 14 from the Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in Bloating Symptoms by Visual Analog Scale (VAS) Improvement in Quality of Life by measuring the Gastrointestinal Quality of Life Index (GIQLI) It will also include the incidence of treatment-emergent adverse events and serious adverse events, as well as changes from baseline in clinical laboratory tests, vital signs, physical examinations and other parameters if any.Timepoint: Day 14 from the Baseline | — |
Countries
India
Contacts
Public ContactSoumya Ranjan Dey
Hi-Tech Medical College and Hospital
Outcome results
None listed