A Randomized, Multi Center, Double Blinded, Placebo-Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the Safety and Immunomodulatory Effects of Coffemune in Healthy Adults

Vidya Herbs Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.peripheral white blood cell (WBC) count greater than 3000 and lesser than 8000 cells/Microliter as measured in the screening test.
•2. No antibiotics use within 1 month prior to entering the study or during the study
•3. Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
•4.Must be willing and able to give informed consent and comply with the study procedures.

•1. Vaccination against influenza within 3 months prior to the screening test
•2. Body mass index (BMI) greater than 18.5 kg/m2 and less than 30 kg/m2 at the time of the screening test
•3. Presence of a clinically acute disease or chronic cardiovascular, endocrine, immune, respiratory, hepatobiliary, kidney, urinary, neuropsychiatric, musculoskeletal, inflammatory, haematological, or gastrointestinal disease;
•4. Subjects with liver and renal disorders (Aspartate Transaminase (AST) Or Alanine Transaminase (ALT) > 3x The Normal Upper Limit Serum Creatinine >2.0 mg/dL)
•5. Subjects with history of Supplementation with medicines or health functional foods associated with immunity enhancement within 1 month prior to the screening test,Administration of antipsychotics within 3 months prior to the screening test,Suspected alcoholism or drug abuse,Recent blood donation ,Any contraindication to blood sampling , Pregnant and Lactating women ,Immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection) ,Allergy to any component of the supplement.
•6. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
•7. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

发起方