Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: Vibrance therapeutic water: 1 Glass of Vibrance therapeutic water (330 mL) in the morning immediately after waking up and 1 Glass of water at least 1 hour after dinner.
Control Interven
Sponsors
Mystic Kingdom Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Male and female participants aged 21-50 years (both inclusive); 2. BMI between 18.5 – 29.9 kg/m2; 3. Participants should self-report at least two of the following gastrointestinal symptoms: epigastric discomfort, heartburn, bloating, nausea, fullness in the stomach, abdominal pain, or anorexia; 4. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26; 5. Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. 6. Subjects with or without type 2 diabetes, if diabetic should be on stable medication for at least the past 3 months and have HbA1c NMT 7.5%.(10 subjects will be enrolled which will be having type 2 diabetes)
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Participants with major abdominal surgery, a history of inflammatory bowel disease or diverticular disease, celiac disease, allergic diseases, including asthma, psychiatric disorders and critical systemic illness as assessed by medical history, appropriate consultations and/or laboratory tests; 2. Actively having a gut infection; 3. History of or complications from malignant tumors; 4. Participant using or had used any probiotics, prebiotics herbs, dietary, nutraceutical, ayurvedic supplements or any other medicines for the digestive health, stress or glycemic control; 5. Females who are pregnant and have a positive urine pregnancy test/planning to be pregnant/lactating or not using reliable methods of contraception; 6. Participants with heavy alcohol consumption or smoking/tobacco consumption; 7. Participation in any other clinical study within the past 3 months or ongoing; 8. Any other reason that, in the opinion of the investigator, excludes the participant from eligibility for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of the study will be to evaluate changes in - 1. Perceived stress scale-10 (PSS-10) score 2. Digestive health using a Gastrointestinal Symptom Rating Scale (GSRS) score. 3. Glycemic control evaluated by: -fasting plasma glucose, postprandial blood glucose -HbA1c Timepoint: at screening, week 2, week 4, and week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study will be to evaluate changes in- 1. Changes in vital signs. 2. Adverse events profile. 3. Compliance and tolerability of the investigational product. Timepoint: at screening, baseline, week 2, week 4, and week 6. | — |
Countries
India
Contacts
Public ContactMs Anamika Kapur
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed