Clinical assessment of Immunomodulatory potential of Immunity Formula in healthy individuals- Parallel arm clinical trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of the Immunity Formula by assessing-
Study Overview
Brief Summary
The Immunity Formula, a blend of natural compounds, vitamins, and minerals, has demonstrated promising immunomodulatory effects in healthy individuals. Research indicates its ability to enhance immune resilience by modulating cytokine production, balancing pro-inflammatory and anti-inflammatory responses, and supporting the activity of innate and adaptive immune cells. Clinical studies highlight improved biomarkers of immune function, including increased natural killer (NK) cell activity and optimized T-cell responses. Additionally, its antioxidant properties help mitigate oxidative stress, further supporting immune health. The formula’s benefits suggest it may serve as a preventive measure to maintain immune system balance and overall well-being in healthy populations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female subjects aged 35 to 60 years (both the ages inclusive)
- •With any one condition prevalent- recurrent upper respiratory tract infection, seasonal asthma, allergic rhinitis, skin allergies
- •Ready to provide written informed consent
- •Subjects with or without the known infection of Covid
- •If known case the Covid 19 infection should not be in the active phase that is within 3 months of infection
- •Subjects with or without vaccinated with SARS Cov 2 vaccine (Any vaccine available in India)
- •No history of any known allergy with herbal products or any of the ingredients of the test product
- •Willing to comply with all requirements of the trial procedure.
- •Subjects with or without comorbidities, if comorbidity exists should be on stable prescription and with following criteria Hypertension (140 by 90 mmHg on prescription), Type 2 DM (HbA1C less than or equal to 7.5 on prescription) etc.
Exclusion Criteria
- •Subject in the active phase of Covid 19 infection or recovered with persistent symptoms or as per discretion of the investigator
- •Patients with known uncontrolled diabetes mellitus (DM) HbA1C more than 7.5 hypertension (HT) symptomatic congestive heart failure (CHF) unstable angina pectoris myocardial infarction (MI)
- •Subjects with a current medical history of any major illness such as cancer, heart disease as per investigator opinion
- •Patients participated in another clinical drug trial within 3 months before recruitment in this trial
- •Any other medical condition that in the Investigators opinion would preclude patient participation
- •Pregnant and breastfeeding women
- •Immunologically compromised individuals
- •Subjects with past history of addiction abuse and rehabilitation.
Outcomes
Primary Outcomes
To evaluate the efficacy of the Immunity Formula by assessing-
Time Frame: 1. screening, and 90 | 2. screening, and 90 | 3. screening, and 90
1. Immunity markers- Changes in immunoglobulin IgG and IgM
Time Frame: 1. screening, and 90 | 2. screening, and 90 | 3. screening, and 90
2. Inflammation markers-Changes in inflammatory markers like CRP, IL-6
Time Frame: 1. screening, and 90 | 2. screening, and 90 | 3. screening, and 90
3. Antioxidant markers-Changes in antioxidant markers like GSH, CAT, SOD
Time Frame: 1. screening, and 90 | 2. screening, and 90 | 3. screening, and 90
Secondary Outcomes
- Clinical markers-(1.Change in fatigue severity score)
Investigators
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital