Effect of Ashwagandha on the Immunity of Healthy Participants

Phase 2

Completed

• Registration Number: CTRI/2018/07/014792
• Lead Sponsor: Arjuna Natural Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in baseline value of Th1 and Th2 cytokines (interferon γ & interleukin-4), between groups. <br/ ><br>2. Change in baseline values of Immunoglobulin (IgG, IgM and IgA) levels between groups <br/ ><br>3. Change in Baseline counts of T- cell (CD3+, CD4+, CD8+), B-cell (CD19+), and NK-cells (CD16+,CD56+) between groups.Timepoint: Baseline, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>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 <br/ ><br>3. Change in Baseline value (Day 0) of Serum cortisolTimepoint: 1. Baseline, Day 30, Day 60 for intervention. <br/ ><br>2. baseline to day 30 of placebo group and baseline (day 30) to day 60 of the crossover group. <br/ ><br>3. Baseline, day 30, day 60.