An Interventional, Randomized, Parallel Group, Placebo Controlled, Three Arm Clinical Study of Beverage Formulations (Formulation 1A and Formulation 1B) to Assess Their Properties towards the Enhancement of Active Energy and Improving Immunity in Healthy Population.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- 2.To assess the efficacy of beverage 1 (formulation 1A and formulation 1B) for the immune-supportive properties assessed through Serum IgG Test
Study Overview
Brief Summary
The purpose of the study is to investigate the improvement in physical energy and immunity in 120 healthy subjects. In the proposed randomized, double-blind, placebo-controlled study, the lower and the higher dose of herbal beverage will be compared against placebo to evaluate the safety and efficacy, and incremental dose effect. The treatment duration of the study will be 4 weeks. The various primary efficacy parameters considered are changes in the serum cortisol levels, in serum IgG levels. Other secondary parameters include estimation of natural killer cells (NK) Cells, 30-meter Fast Paced Walk Test, 30 Seconds Chair Stand Test, 10 Steps Stair Test.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Adults healthy subjects willing to provide a written Informed Consent 2.BMI:
- •25 kg/m2 3.No prior history of any allergy 4.Subjects with borderline immunity.
- •IgG levels (600 – 799 mg/dl).
Exclusion Criteria
- •1.Severe Immunosuppressed Subjects with IgG levels lower than 300 mg/dl 2.Chronic Smokers (more than 3 cigarettes/day) 3.Chronic alcoholics (more than 2 standard pegs/day) 4.Subjects with known secondary causes of hypogammaglobulinemia such as nephrotic syndrome, renal disease, malignancy, etc 5.Subjects taking immunosuppressants medications 6.Pregnant women or women planning for pregnancy during the study period 7.Subjects with known Hypertension and other diseases of the cardiovascular system.
- •8.Subjects with known Liver diseases, Kidney diseases, Psychiatric diseases, Epilepsy and/or with any other relevant diseases 9.Subjects with the intention of non-compliance to the study protocol 10.Subjects participating in any another clinical trial simultaneously 11.Retraction of the written informed consent 12.Subjects currently taking medications other than oral contraceptive pill 13.Any other medical condition that in the Investigators opinion would preclude patient participation 14.Any antibiotic use in the past one week prior to entering the study 15.History of vaccination such as seasonal influenza vaccine in the past 2 months 16.Subjects taking health supplements 17.Subjects with deteriorating health status at the time of enrollment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhoea, irritable bowel syndrome etc.).
Outcomes
Primary Outcomes
2.To assess the efficacy of beverage 1 (formulation 1A and formulation 1B) for the immune-supportive properties assessed through Serum IgG Test
Time Frame: 1.Time Frame: Baseline and 30th Day | 2.Baseline, 30th Day & 60th Day assessment for 60 subjects only
1.To assess the efficacy of beverage 1 (formulation 1A and formulation 1B) for its active energy properties assessed through level of serum cortisol
Time Frame: 1.Time Frame: Baseline and 30th Day | 2.Baseline, 30th Day & 60th Day assessment for 60 subjects only
Secondary Outcomes
- 1.To assess the Efficacy of Beverage 1 for its active energy properties assessed through(a.30-meter Fast Paced Walk Test)