Effect of Ashwagandha on the Immunity of Healthy Participants

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/07/014792

Enrollment

Registered

2018-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ShodenÂ®(Withania somnifera extract): ShodenÂ® 180 mg containing 21mg glycowithanolides. Dose - 1 capsule of ShodenÂ® once daily before breakfast. Study period - 30 days intake Extens

Eligibility

Inclusion criteria

Inclusion criteria: 1. BMI 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

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.

Design outcomes

Primary

Measure	Time frame
1. Change in baseline value of Th1 and Th2 cytokines (interferon Î³ & interleukin-4), between groups. 2. Change in baseline values of Immunoglobulin (IgG, IgM and IgA) levels between groups 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

Measure	Time frame
1. Within the group comparison for the change in baseline value of Th1 and Th2 cytokines (interferon Î³ & 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 Î³ & interleukin-4), Immunoglobulin (IgG, IgM and IgA), and TBNK cell count levels 3. Change in Baseline value (Day 0) of Serum cortisolTimepoint: 1. Baseline, Day 30, Day 60 for intervention. 2. baseline to day 30 of placebo group and baseline (day 30) to day 60 of the crossover group. 3. Baseline, day 30, day 60.	—

Measure

Time frame

1. Within the group comparison for the change in baseline value of Th1 and Th2 cytokines (interferon Î³ & 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 Î³ & interleukin-4), Immunoglobulin (IgG, IgM and IgA), and TBNK cell count levels 3. Change in Baseline value (Day 0) of Serum cortisolTimepoint: 1. Baseline, Day 30, Day 60 for intervention. 2. baseline to day 30 of placebo group and baseline (day 30) to day 60 of the crossover group. 3. Baseline, day 30, day 60.

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Countries

India

Contacts

Public ContactDr Binu T Kuruvilla

Arjuna Natural Ltd (Formerly Arjuna Natural Extracts Ltd)

drbinu@arjunanatural.com09447818432

Outcome results