CTRI/2024/01/061852
Not yet recruiting
Phase 2
Pharmacokinetics and Immunomodulatory Potential of Withania somnifera and Tinospora cordifolia in Healthy Volunteers- A Proof of Concept Study: A randomized, open label, two period, multiple doses, oral pharmacokinetic study - NI
Institute of Teaching and Research in Ayurveda, Jamnagar 361008, Gujarat, India0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institute of Teaching and Research in Ayurveda, Jamnagar 361008, Gujarat, India
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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