CTRI/2023/06/054557招募中4 期
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 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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