A Randomized, Placebo controlled, double blinded, parallel groupclinical study to evaluate the efficacy and safety of IAI01 (Kutki) as animmunomodulator in adult and elderly population.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. Assessment of absolute, naïve, effector and memory cell counts of B and T-Cells [ Time Frame: Baseline and Day 30]
Study Overview
Brief Summary
The selected 60 participants will be randomized into 2 groups with 30 in each group.
- Test Group -Participants without any active illness
Out of 30 participants, 10 will be in the age group of 45-54 years, 10 will be in the age group of 55-64 years and 10 will be in the age group of 65-75 years.
- Placebo Group- Age and sex-matched participants like that of test group without any active illness. All key co-interventions will be documented.
The primary outcome: Assessment of absolute, naive, effector and memory cell counts of B and T-cells (time frame BAseline day,30)
Change from baseline in the following lab parameters namely, CBC, ESR,RBS, HbA1c, CRP, LFT<RFT, Lipid profile and Serum electrolytes(Tiem Frame, BAseline, Day 15 (except HbA1c, day 30)
Change from baseline in IL-2, IL-4, IL-10 and P53 levels (Time BAseline and Day 30)
Secondary Outcome
To monitor for any adverse events during the study period and assess the quality of life using a pre-and-post feedback questionnaire
Number of sick days
Incidence and Duration (days ) of hospitalization if any(Time frame: through Day 30)
The results of the placebo and treatments arm will be analaysed and compared
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 45.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Willing and able to provide written informed consent prior to performing study procedures.
- •Adult patients aged more than 45 years with or without co morbidities like hypertension and Diabetes mellitus, who are on regular treatment.
Exclusion Criteria
- •Participants with any active illness or infections including COVID
- •Patient having HIV infection.
- •Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
- •Have had cancer.
- •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.
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
- •Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR< 30)
- •Immuno-compromised patients on medications.
- •Patients who are on medication of immuno supressors/steroids/antibody (mAb etc), whether injectables/oral/topical, for their other health condition
- •Participation in any other clinical trial of an experimental treatment in the past 3 months.
- •Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment.
Outcomes
Primary Outcomes
1. Assessment of absolute, naïve, effector and memory cell counts of B and T-Cells [ Time Frame: Baseline and Day 30]
Time Frame: DAY 1, DAY 15, DAY 30
2. Change from baseline in the following lab parameters namely,
Time Frame: DAY 1, DAY 15, DAY 30
CBC, ESR, RBS, HbA1c, CRP, LFT, RFT, Lipid profile and Serum electrolytes. [Time frame: Baseline, Day 15 (Except HbA1c) and Day 30]
Time Frame: DAY 1, DAY 15, DAY 30
3. Change from baseline in IL-2, IL-4, IL-10 and P53 levels [Time frame: Baseline and Day 30]
Time Frame: DAY 1, DAY 15, DAY 30
Secondary Outcomes
- 1.To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire.(2. Number of sick days)