None listed
Conditions
Interventions
None listed
Sponsors
Institute of Teaching and Research in Ayurveda, Jamnagar 361008, Gujarat, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers willing to participate and sign consent 2. Apparently healthy, non-smoking, non-alcoholic male volunteers of 20 to 30 years of age 3. Volunteers who have no history of major diseases and medication in preceding six months 4.No history of cold and fever in preceding one month 5. BMI in the range of 18 – 25 (both inclusive) 6. Volunteers with normal Chest X-ray, ECG, CBC, Urine (routine) reports 7. Resting pulse rate ranging between 60 to 90 beats/min 8. Volunteers with clinical biochemistry not to exceed the upper limit of normal [fasting blood sugar (FBS), alanine aminotransferase (ALT) and aspartate aminotransferase (AST), blood urea and creatinine, total cholesterol and triglyceride 9. Volunteers who are eligible as per the following criteria of health mentioned by Kashyapa •Desire for food •Easy digestion of ingested food •Proper excretion of feces, urine, flatus •Proper functioning of eyes, ears, nose, tongue •Comfortable sleep, easy awakening •Attainment of strength (no fatigue/weakness) •Healthy complexion •Proper digestive fire (good hunger)
Exclusion criteria
Exclusion criteria: 1. Volunteers who report discomfort on exercise 2. Volunteers who are not willing for pharmacokinetic study 3. Any concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of study 4. Volunteers on any ayurvedic and/or herbal formulation to boost immunity since preceding one month of study 5. Any clinically relevant history or the presence of autoimmune, respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric behavioral, etc. 6. History of consumption of alcohol, antibiotics, or anti-tuberculosis medicines in past 6 months. 7. The opinion of the investigator poses an unacceptable risk to the volunteer in this study 8. Volunteers who are on immuno-suppressants like steroids, methotrexate, azathioprine, etc. 9. Volunteers who are likely to migrate or travel out of Pune for the next three months. 10. Have any bleeding disorder or sensitivity to heparin which is considered as a contraindication to intramuscular injection or blood draw. 11. Administration of blood, blood products and/or plasma derivatives or any vaccine (other than COVID-19 vaccine) or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period 12. Current or planned participation in prophylactic drug trials of any investigational or non-registered drug or vaccine for the duration of the study 13. Individuals who are part of study team or close family members of individuals conducting this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile of various phytoconstituents and safety data will be generated (at SPPU & ITRA) Timepoint: Pharmacokinetics(PK)- Days 1-2 (period 1) and Days 90-91 (period 2) of entire study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunophenotype & cytokine secretion by PBMC stimulated with viral antigen (at SPPU)Timepoint: Days 0 & 90 ;Insulin (fasting), blood glucose (fasting), HOMA-IR, advanced glycation end products, erythropoietin, IGF-1 & myostatin, body fat analysis, alkaline phosphatase (bone-specific), serotonin, testosterone, Protein carbonyl, lipid peroxidation, 8-OHdG (8-hydroxy-2’-deoxyguanosine) (at SPPU & ITRA)Timepoint: Days 0 & 90;WHO Quality of Life Brief Version (WHOQOL-BREF) Questionnaire, 5-item World Health Organization Well-Being Index (at SPPU & ITRA)Timepoint: Days 0, 45, & 90 | — |
Countries
India
Contacts
Public ContactDr Preeti Chavan Gautam
Institute of Teaching and Research in Ayurveda, Ministry of AYUSH Government of India
Outcome results
None listed