None listed
Conditions
Interventions
Intervention1: Youniqor: Dose: Two sachets (containing 3,600 mg each) per day i.e. 7,200 mg per day
Regimen: 1 sachet containing 3,600 mg twice a day to be dissolved in 100 mL water and taken with mea
Sponsors
YOXLO B. V.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals willing to give written informed consent to participate in the study. 2. Healthy men and women aged 60 to 80 years (both values included). 3. Individuals with Body Mass Index (BMI) 22.5 to 29.9 kg per meter square (both values included). 4. Individuals with hsCRP levels 0.7 to 5.0 mg per Liter (both values included). 5. Individuals willing to avoid specific training and or practice on the muscle and or cognition endpoints during the study. 6. Compliance with the requirements of the entire protocol. 7. Individuals willing to follow all the study procedures and follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Individuals with chronic/inflammatory or cardiometabolic disease requiring daily medication. 2. Presence of uncontrolled diabetes mellitus (Indicated by fasting blood glucose greater than or equal to 126 mg/dL). 3.Individuals with hypertension. 4. Individuals with eGFR less than 60 mL/min/1.73 m . 5. Individuals with AST/ALT greater than 2 Upper Limit of Normal (ULN). 6. Individuals with WBC count below 3500/mm3. 7. Individuals with any ongoing or history of acute infection within past 2 weeks. 8. Individuals with recent vaccination within past 4 weeks. 9. Individuals having known allergy/intolerance to N-acetyl-L-cysteine (NAC) or glycine. 10. Individuals who have targeted practice on study endpoints. 11. Diagnosed with neurodegenerative, neurological or other major psychiatric disorders. 12. Any other conditions which may, in the Investigator s opinion, be accompanied by anemia, chronic diseases or anticoagulation therapy. 13. Individuals who are on systemic corticosteroids, immunosuppressants or chronic pain medications. 14. Participation in other clinical trials in last 90 days prior to screening. 15. Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigator s clinical judgment. 16. Current smokers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety profile of Youniqor by assessing the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs).Timepoint: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of Youniqor in comparison to baseline on Vitals like Blood pressure, Pulse rate, Peripheral oxygen saturation.Timepoint: Day 0, Day 28, Day 56; To assess the effect of Youniqor in comparison to baseline on Hematology: Hb, Hct, RBC, WBC count (total + differential), platelets count.Timepoint: Day 0, Day 28, Day 56;To assess the effect of Youniqor in comparison to baseline on a.Electrolyte: Na+, K+, Cl- b. Blood urea nitrogen, Creatinine + estimated glomerular filtration rate c. Fasting Blood Glucose d. Liver Function Test [Aspartate aminotransferase, Alanine aminotransferase, Gamma-glutamyl transpeptidase, Alkaline phosphatase, Total Bilirubin, Total Proteins e. Complete Lipid panel for Low-density lipoprotein, High-density lipoprotein, Triglycerides, Total Cholesterol, Very low density lipoproteinTimepoint: Day 0, Day 28, Day 56;To assess the effect of Youniqor in comparison to baseline on Urine examinationTimepoint: Day 0, Day 28, Day 56;To assess the effect of Youniqor in comparison to baseline on 12-lead ElectrocardiogramTimepoint: Day 0 and Day 56 | — |
Countries
India
Contacts
Public ContactDr Kishori Pashte
Vedic Lifesciences Pvt Ltd
Outcome results
None listed