None listed
Conditions
Interventions
Intervention1: Hydron Alkaline Ionized Water (HAIW): Subject will be asked to consume HAIW as and even required for 30 days.
Control Intervention1: Packaged Drinking water: Subject will be asked to co
Sponsors
Hydron Alkaline Aqua Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Cohort 1: 1. Healthy males and females with any of the mild to moderate symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain, or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, flatulence, indigestion, and appetite. 2. Subjects must be suffering from any of the above symptoms at least from last six months. 3. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. Cohort 2: 1. Male or female subjects presenting with any two symptoms i.e. straining during defecation, lumpy or hard stool, sensation of incomplete evacuation, sensation of anorectal blockade for the last 3 months 2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study
Exclusion criteria
Exclusion criteria: Cohort 1: 1. Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart disease, cancer, kidney failure, chronic liver diseases, 2. Subjects having jaundice or any other symptom of active hepatitis 3. Subjects with any other investigational product within 1 month prior to randomization 4. Subject suffering from any other functional dyspepsia, or any other functional gastrointestinal disorder 5. Subjects with diabetes mellitus and hypertension taking regular medications 6. Pregnant and lactating women 7. Subjects with any significant abnormal laboratory parameters 8. Known hypersensitivity to study products 9. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol. Cohort 2: 1. Subjects diagnosed with colonic inertia., have recently undergone abdominal surgery, history of anorectal surgery. 2.Subjects having other functional gastrointestinal disorders other than Functional constipation 3. Subjects diagnosed with structural abnormalities 4. Subjects with uncontrolled DM and hypertension and Tuberculosis. 5. Known cases of HIV, tuberculosis, hypo and hyperthyroidism 6. Known cases of renal or liver dysfunction. 7. Subjects diagnosed with neurological 8. Subjects on chronic medication greater than 60 days and or who are on medications known to cause constipation. 9. Pregnant or lactating females 10. Subjects allergic to Hydron Alkaline Ionised Water (HAIW) or packaged drinking water 11. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Change in severity of gastrointestinal symptoms assessed on graded scale Cohort 2: Change in frequency of bowel movements Timepoint: Baseline visit, day 15 and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: 1. Changes in duration, number of episodes and severity of symptoms on graded scale 2. Changes in indigestion and appetite 3. Global assessment for overall change by investigator and subject 4. Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms 5. Assessment of adverse events Cohort 2: 1. Changes in indigestion and appetite on graded scale 2. Changes in symptoms of functional constipation on graded scale 3.Changes in associated clinical symptoms on graded scale 4. Global assessment of overall change as per the investigator and subject 5. Assessment of tolerability of study product as per the investigator and subject by assessing Adverse Events, Adverse Drug Reactions Timepoint: Baseline visit, day 15 and day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed