To Evaluate The Safety and Efficacy of KSM-66 Ashwagandha®capsule (300 mg) on Immune Function Enhancement and Quality of Life (QoL) in Healthy Subjects

Not Applicable

Completed

• Registration Number: CTRI/2022/02/040494
• Lead Sponsor: Ixoreal Biomed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-15
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Adult males and females between 18 to 60 years of age. (Apparently healthy, as determined by medical history, physical examination)

2. Subjects with Immune Status Questionnaire of less than 6

3. Participants who agree to take investigational product (i.e., Till day 56)

4. Literate subject willing to give signed informed consent.

5. Willing to comply with study protocol requirements.

Exclusion Criteria

1. Participants who are not willing to take investigational product.

2. Any acute illness which may hamper the study participation as per PI discretion at the time of enrollment.

3. Individual participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.

4. Patients with uncontrolled, unstable comorbidities.

5. Individuals with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease.

6. History of allergic reactions or anaphylaxis to investigational product components.

7. Participants with a history of or those currently on immunosuppressants.

8. Pregnant and lactating females.

9. Any other condition which the principal investigator thinks may jeopardize the safety of subjectsâ??patients with uncontrolled, unstable comorbidities.

10. Those with a history of clinically significant hypersensitivity reactions to immunomodulators. 11. Those with thyroid or pituitary disease

12. Those with immune system disease

13. Those with a history of systemic diseases such as multiple sclerosis, allergic skin disease and other autoimmune diseases

14. Those with a BMI of less than 18.5 kg/m2 at screening

15. Those who have received antipsychotic medication within 2 months before screening

16. Those with a alcoholism or history of substance abuse

17. Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation)

18. Participation in a clinical study during the preceding 90 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified