A clinical study to assess the safety and immunity enhancement effect of Coffemune in healthy subjects.

Not Applicable

• Registration Number: CTRI/2021/01/030523
• Lead Sponsor: Vidya Herbs Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Immunity MarkersTimepoint: Day 0, Day 84

Secondary Outcome Measures

Name	Time	Method
Change in Fatigue levelsTimepoint: Day 0, Day 42, Day 84;Change in Quality Of LifeTimepoint: Day 0, Day 42, Day 84;Safety of the productTimepoint: Day 0, Day 42, Day 84