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To know the effect of test product (AP-Bio®/KalmCold® capsules) in improving the immunity (Ability to protects the body against disease or other potential damaging foreign bodies) in healthy adults.

A Prospective Open Label, Single Center, Single-Arm Trial to evaluate the efficacy of AP-Bio®/KalmCold® Capsules in enhancing the immunity and to evaluate its safety in healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024903
Enrollment
30
Registered
2020-04-28
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: AP-Bio®/KalmCold® Capsules 100mg: One capsule 100mg twice daily at fixed time in the day for 4 weeks (30 days) Control Intervention1: Not Applicable: Not Applicable

Sponsors

Health Care Company Natural Products
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female subjects aged between 18-60 years with BMI 18 to 30 kg/m2. 2.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the Investigator. 3.Devoid of any medication during last one month. 4.Subject provides written informed consent and comes for regular follow up.

Exclusion criteria

Exclusion criteria: 1.Female subjects who are pregnant, lactating or planning to become pregnant during the study period. 2.Subjects receiving influenza vaccination within 3 months before the screening examination. 3.Subjects with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic. 4.Subjects suffering from different diseases/disorders and/or having any kind of allergy, undergone surgery during last one year. 5.Subjects who have received organ transplant, chronic smokers, underlying conditions which might affect immunity. 6.Subjects who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening examination. 7.Subjects receiving antipsychotic medication within 3 months prior to the screening examination. 8.Subjects who is alcoholic or drug abuse suspected. 9.Subjects who have participated in other clinical trials within 3 months prior to the screening examination.

Design outcomes

Primary

MeasureTime frame
Change in NK cell count measured using flow cytometryTimepoint: Day -1, Day 3, Day 7 and Day 30—

Secondary

MeasureTime frame
Changes in cytokines Changes in T cell counts Treatment Emergent Adverse events (AEs) frequency and severityTimepoint: Day -1, Day 3, Day 7 and Day 30—

Countries

India

Contacts

Public ContactMr Vijay Bhaskar

InVitro Research Solutions Pvt. Ltd

preethi@ivrs.org.in9900515364

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026