To assess the efficacy and safety of an Immunostimulant supplement on the immunity of healthy human subjects

Completed

• Conditions: Immunostimulant supplement on the immunity of healthy human subjects

• Registration Number: CTRI/2021/07/035206
• Lead Sponsor: OmniActive Health Technologies

Brief Summary

A prospective, randomized, double-blind, multipledose, parallel, placebo-controlled, clinical interventional study, proof ofconcept study on healthy human subjects.Single tablet to be taken preferably in the morningafter breakfast for 2 months.Approximately 30 healthy male or non-pregnant,non-lactating female subjects age between ≥ 30 and ≤ 70 years who frequentlysuffer from cold, flu, and fever shall be enrolled into the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-08
• Study Completion: 2021-10-13
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Healthy male or non-pregnant, non-lactating female human subjects between age of ≥ 30 and ≤ 70 years who frequently suffers from cold, flu, and fever.
• 2.Subjects who smoke and willing to abstain from smoking and consuming tobacco throughout the study duration.
• 3.Subjects who consume alcohol and willing to abstain from consuming alcohol throughout the study duration.
• 4.Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation at baseline measurement.
• 5.Subjects willing to avoid anti-inflammatory/immunostimulant/ immunosuppressant medications during the study period.
• 6.Female subjects of childbearing potential practicing an approved method of contraception and willing to continue its use throughout the study duration or female subjects of non-childbearing potential.
• 7.Subjects willing to provide written consent.
• 8.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.

Exclusion Criteria

• 1.History or evidence of hypersensitivity to any ingredient from the formula or its metabolites.
• 2.Subjects with clinically significant disease(s) or disorder(s) in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
• 3.History of hypo and hyperthyroidism.
• 4.Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, anemia, dysphagia, or abdominal mass.
• 5.History of milk, gluten allergies, or other known food intolerances and/or any food allergies.
• 6.History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash.
• 7.Subjects taking ace-inhibitors, cholesterol-lowering medications.
• 8.History of difficulty with donating blood or difficulty in the accessibility of veins.
• 9.Receipt of any prescription drugs or over-the-counter drugs (e.g.: cough and cold preparations, antacid preparations and natural products used for therapeutic benefits) within 30 days before screening.
• 10.Current use of an immunostimulant/immunosuppressant supplement.
• 11.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
• 12.Female subjects with positive Urine Pregnancy Test at the screening.
• 13.Subjects who have been treated with any investigational drug or investigational device within 3 months before study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Mean change from baseline on immunity as determined by laboratory parameters	•Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)
•Mean change from baseline on stress as determined by Perceived Stress Scale	•Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)
•Mean change from baseline on sleep as determined by PSQI	•Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)

Trial Locations

Locations (1)

Telerad RxDx Healthcare Pvt. Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Telerad RxDx Healthcare Pvt. Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Belliappa C M A

Principal investigator

9880673579

belligp_2000@yahoo.co.uk