CTRI/2023/06/054557
Recruiting
Phase 4
An interventional, open-label, prospective, single-arm clinical study of Good Monk-a nutrition mix formulation for the assessment of gut health, energy enhancement,immune supportive properties,growth & well-being on healthy population. - NI
Superfoods Valley Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Superfoods Valley Private Limited
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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