To study the effects of herbal supplement on improvement in general health condition in healthy population.
- Registration Number
- CTRI/2019/02/017529
- Lead Sponsor
- Coca Cola India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1.Adults Healthy Subjects willing to provide a written Informed Consent
2.Age group: 18 - 45 Years
3.BMI: 18 - 25 kg/m2
4.No prior history of any allergy
5.Subjects with borderline immunity - IgG levels (600 â?? 799 mg/dl)
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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the efficacy of beverage 2 (formulation 2A and formulation 2B) for the Immune-supportive properties through serum IgG test. <br/ ><br>2.To assess the efficacy of beverage 2 (formulation 2A and formulation 2B) for General Health Properties Improvement using Quality of Life (QoL) scale for normal health.Timepoint: 1.Baseline, 30th Day & 60th Day <br/ ><br>2.Baseline, 7th Day, 15th Day, 21st Day & 30th Day
- Secondary Outcome Measures
Name Time Method 1.NK Cells Estimation Test (for 20% of subjects) <br/ ><br>2.Profile of mood states (POMS) Scale <br/ ><br>3.Cohenâ??s Perceived Stress Scale Questionnaire (PSSQ) <br/ ><br>4. Safety assessmentsTimepoint: 1.Baseline and 30th Day <br/ ><br>2.Baseline & 30th <br/ ><br>3.Baseline, 7th Day, 15th Day, 21st Day & 30th Day <br/ ><br>4.Baseline and 30th Day