None listed
Conditions
Interventions
Intervention1: Good Monk: Micronutrients+Probiotics+Lysine+Herbs for 120 days
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Superfoods Valley Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects between the ages groups of 13 years to 35 years who have a history of either any of the important micronutrient deficiency (Vit.B12, Vit.D, Iron) or a gut related dysfunction or the combination of both. 2. Subjects willing to participate and comply with the protocol procedures by signing an Informed Consent Form to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with the current habit or history of cigarette smoking and alcohol consumption. 2. Subjects with any known significant systemic disease/ disorder, i.e. hepatic, renal, oesophageal, gastrointestinal, cardiovascular, psychological, neurological etc. 3. Subjects on any seizure medication. 4. Subjects on any other medication known to reduce immunoglobulin levels. 5.Subjects with a known history of any malignant disease. 6. Subjects with known history of autoimmune disease and other systemic diseases related to immune system. 7. Subjects with chronic immune diseases like HIV. 8. Subjects suffering with the infectious diseases HBsAg. 9. Subjects treated with the following medications: a) Antibiotics less than one week before the study b) Any vaccination less than 4 weeks before the study c) Concomitant immunosuppressive or immune-stimulating therapy 3 months before the study start. d) Concomitant medication/ therapy for gut related disorder/s. e) Concomitant medication/ therapy for micronutrient supplementation. f) Concomitant medication/ therapy for micronutrient supplementation. 10. Subjects who participated in another clinical trial less than 3 months prior to this study. 11. Subjects who are suffering from any communicable disease. 12. Female subjects, who are pregnant, breast feeding or expecting pregnancy during the study period. 13. Subjects with the history of consumption of any recreational drugs (such as cocaine, methamphetamine, marijuana, etc). 14. Subjects who are scheduled for any surgery within 3 months period of completing the study. 15. Subjects who are pre-diabetic/ diabetic or hypertensive or hyperlipidemic 16. Subjects with inability or unwillingness to abide by the requirements of the protocol. 17. Subjects who are incompetent to sign an Informed Consent Form. 18. Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut health parameters Energy parameters Growth parameters Immunity parameters Micronutrients parametersTimepoint: 0 Day, 30 Day, 60 Day, 120 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of incidences of falling Sick/ catching infections 2.Safety Laboratory Tests 3.Health Questionnaires 4.Treatment-emergent adverse eventsTimepoint: 0 Day, 30 Day, 60 Day, 120 Day 0 Day, 120 Day 0 Day, 30 Day, 60 Day, 120 Day 0 Day, 30 Day, 60 Day, 120 Day | — |
Countries
India
Contacts
Public ContactMs Ankita Gupta
Superfoods Valley Private Limited
Outcome results
None listed