CTRI/2024/01/061852尚未招募2 期
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 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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)
排除标准
- •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
研究者
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