CTRI/2018/07/014792已完成2 期
A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension to Assess the Immunomodulatory Effects of Ashwagandha (Withania Somnifera) Extract on Healthy Participants
Arjuna Natural Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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. BMI <30.0
- •2. Healthy participants (health status confirmed by clinical history , Physical Exam and routine blood analysis)
- •3. The participant must not have taken any vitamin / mineral/ dietary or herbal supplements 1 month prior to enrolling in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion.
- •4. Participant must be able, willing and likely to fully comply with study procedures and restrictions.
- •5. Participant willing to sign the informed consent
排除标准
- •1. Participant suffering from different diseases/disorders and/or having any kind of allergy.
- •2. Participant with or having prior history of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •3. BMI > 30.0
- •4. Pregnant/lactating women
- •5. Undergone surgery during last one year.
- •6. Received organ transplantation.
- •7. Chronic smokers.
- •8. Alcohol or drug abuse
- •9. Participant taking any other investigation drug and currently being a part of any other clinical trial/research.
- •10. Any other underlying conditions which might affect immunity and/or the evaluation of the response of the study medication.
- •11. Participants with known hypersensitivity to test drug.
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