CTRI/2023/11/060043尚未招募2 期
Immunomodulatory Potential of Withania somnifera and Tinospora cordifolia in Healthy Volunteers- A Proof of Concept Study - NI
Institute of Teaching and Research in Ayurveda, Jamnagar0 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
- •3. Volunteers who have no history of major diseases and medication in preceding six
- •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)
排除标准
- •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
- •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
研究者
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