Rasayana effects of Ashwagandha and Guduchi in Healthy Volunteers

Phase 2

Registration Number: CTRI/2023/11/060043

Lead Sponsor: Institute of Teaching and Research in Ayurveda, Jamnagar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 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

1) Volunteers who report discomfort on exercise

2) Any concomitant disease or condition that could interfere with, or treatment of which might

interfere with, the conduct of study

3) Volunteers on any ayurvedic and/or herbal formulation to boost immunity since preceding

one month of study

4) Any clinically relevant history or the presence of autoimmune, respiratory, renal, hepatic,

gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric

behavioral, etc.

5) History of consumption of alcohol, antibiotics or antituberculosis medicines in past 6

months.

6) The opinion of the investigator poses an unacceptable risk to the volunteer in this study

7) Volunteers who are on immuno-suppressants like steroids, methotrexate, azathioprine etc.

8) Volunteers who are likely to migrate or travel out of Jamnagar for the next three months.

9) Have any bleeding disorder or sensitivity to heparin which is considered as a

contraindication to intramuscular injection or blood draw

10) 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

11) Current or planned participation in prophylactic drug trials of any investigational or non registered drug or vaccine for the duration of the study

12) Individuals who are part of study team or close family members of individuals

conducting this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WHO Quality of Life Brief Version (WHOQOL-BREF) Questionnaire, 5-item World Health Organization Well-Being Index (ITRA & SPPU) <br/ ><br>Immunophenotype and cytokine secretion by PBMC stimulated with viral antigen(SPPU) <br/ ><br>Timepoint: Day 0, Day 45 and Day 90

Secondary Outcome Measures

Name	Time	Method
Insulin (fasting), blood glucose (fasting), HOMA-IR, advanced glycation end products, erythropoietin, IGF-1 and myostatin, body fat analysis, alkaline phosphatase (bone-specific), serotonin, testosterone, Protein carbonyl, lipid peroxidation, 8-OHdG (8-hydroxy-2’-deoxyguanosine).Timepoint: Day 0, Day 45 and Day 90