Effect of Kutki as animmune booster in adult and elderly population.

Phase 2

Completed

• Registration Number: CTRI/2021/08/035738
• Lead Sponsor: InnAdapt Immune

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-25
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Willing and able to provide written informed consent prior to performing study procedures.

2. Adult patients aged more than 45 years with or without co morbidities like hypertension and Diabetes mellitus, who are on regular treatment.

Exclusion Criteria

1. Participants with any active illness or infections including COVID19.

2. Patient having HIV infection.

3. Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.

4. Have had cancer.

5. Have received any of the following within 3 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.

6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)

7. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)

8. Immuno-compromised patients on medications.

9. Patients who are on medication of immuno supressors/steroids/antibody (mAb etc), whether injectables/oral/topical, for their other health condition

10. Participation in any other clinical trial of an experimental treatment in the past 3 months.

11. Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of absolute, naïve, effector and memory cell counts of B and T-Cells [ Time Frame: Baseline and Day 30] <br/ ><br>2. Change from baseline in the following lab parameters namely, <br/ ><br>CBC, ESR, RBS, HbA1c, CRP, LFT, RFT, Lipid profile and Serum electrolytes. [Time frame: Baseline, Day 15 (Except HbA1c) and Day 30] <br/ ><br>3. Change from baseline in IL-2, IL-4, IL-10 and P53 levels [Time frame: Baseline and Day 30] <br/ ><br>Timepoint: DAY 1, DAY 15, DAY 30

Secondary Outcome Measures

Name	Time	Method
1.To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire. <br/ ><br>2. Number of sick days <br/ ><br>3. Incidence and Duration (days) of hospitalization if any. <br/ ><br>[ Time Frame: through Day 30 ] <br/ ><br>Timepoint: DAY 1, DAY 15, DAY 30