Health Condition 1: K319- Disease of stomach and duodenum, unspecified
Conditions
Interventions
None listed
Sponsors
AMBITN LIFESCIENCES
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and female subjects aged above 18 years with clinical diagnosis of Functional Gastrointestinal Disorder (FGID). 2. Subjects with mild to moderate gastrointestinal clinical symptoms, based on a GSRS. 3. Subjects with stable dietary and lifestyle patterns for the last 4 weeks 4. Willingness to comply with study procedures and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of antibiotics, probiotics, prebiotics, or GI-targeting supplements in past 4 weeks 2. Subjects with organic GI diseases (IBD, celiac disease, peptic ulcer disease, GI malignancy) 3. History of gastrointestinal surgery within the past year 4. Severe psychiatric illness or any systemic disease deemed unsafe by the investigator 5. Pregnant or lactating women, or women planning to become pregnant during the study period. 6. Known allergy or hypersensitivity to any component of the investigational product 7. Use of any medications, supplements, or herbal products specifically intended for the treatment or management of liver disorders within the last 30 days. 8. Participation in any other clinical trial within 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in composite GI symptom score using a GSRS from baseline to different study visits.Timepoint: 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mean change in the Gastrointestinal Quality of Life Index (GI-QoLI) from baseline to end of the study.Timepoint: 28 days. | — |
Countries
India
Contacts
Public ContactManik Chaudhuri
J. B. Roy State Ayurvedic Medical College and Hospital
Outcome results
None listed