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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. Change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), between groups.
研究概览
简要总结
This study is a randomized, placebo controlled, double blinded study to evaluate the immunomodulatory effects of ashwagandha on healthy participants aged 45 to 72 years. There will be a total of 24 participants both males and females. The double blinded study is for a period of 30 days. After that all the participants will be given ashwagandha in an open label extension study for 30 days. This study will evaluate the change in cytokine, immunoglobulins, and total T-cells, B-cells, and NK-cells from baseline to end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 72.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy participants (health status confirmed by clinical history , Physical Exam and routine blood analysis)
- •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.
- •Participant must be able, willing and likely to fully comply with study procedures and restrictions.
- •Participant willing to sign the informed consent.
排除标准
- •Participant suffering from different diseases/disorders and/or having any kind of allergy.
- •Participant with or having prior history of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •Pregnant/lactating women
- •Undergone surgery during last one year.
- •Received organ transplantation.
- •Chronic smokers.
- •Alcohol or drug abuse
- •Participant taking any other investigation drug and currently being a part of any other clinical trial/research.
- •Any other underlying conditions which might affect immunity and/or the evaluation of the response of the study medication.
- •Participants with known hypersensitivity to test drug.
结局指标
主要结局
1. Change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), between groups.
时间窗: Baseline, Day 30, Day 60
3. Change in Baseline counts of T- cell (CD3+, CD4+, CD8+), B-cell (CD19+), and NK-cells (CD16+,CD56+) between groups.
时间窗: Baseline, Day 30, Day 60
2. Change in baseline values of Immunoglobulin (IgG, IgM and IgA) levels between groups
时间窗: Baseline, Day 30, Day 60
次要结局
- 1. Within the group comparison for the change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), Immunoglobulin (IgG, IgM and IgA) and TBNK cell counts.(2. Comparison of the change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), Immunoglobulin (IgG, IgM and IgA), and TBNK cell count levels)