None listed
Conditions
Interventions
Intervention1: Formulation 3A: Contains base dosages of Withania somnifera (Ashwagandha) &
Ocimum sanctum L (Tulasi) and excipients
300mL beverage
Once Daily to be taken orally for one month.
Intervention2: Formulation 3B: Contains enhanced dosages of Withania somnifera (Ashwagandha) &
Ocimum sanctum L (Tulasi)
Once Daily to be taken orally for one month.
Control Intervention1: Placebo: Identical beverage
300mL
Once Daily to be taken orally for one month.
Sponsors
Coca Cola India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adult healthy subjects willing to provide a written Informed Consent 1.Age group: 18 - 45 Years 2.BMI: 18 - 25 kg/m2 3.No prior history of any allergy 4.Subjects with borderline immunity - IgG levels (600 - 799 mg/dl)
Exclusion criteria
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the Efficacy of Beverage 3(formulation 3A and formulation 3B) for its anti-stress properties through Hamilton Anxiety Rating (HAM-A) Scale 2.To assess the Efficacy of Beverage 3(formulation 3A and formulation 3B) for its Immunity properties through Serum IgG TestTimepoint: 1.Baseline,7th,15th,21st,& 30th Day 2.Baseline, 30th, & 60th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the efficacy of beverage 3(formulation 3A and formulation 3B) for its anti-stress through Cohenâ??s perceived stress questionnaire (PSSQ-20) 2.To assess the efficacy of beverage 3(formulation 3A and formulation 3B) for its immunity properties through Immune-supportive properties in 20% Study Population as assessed through NK cells estimation test 3.To assess the Safety of Beverage 3(formulation 3A and formulation 3B) at baseline and end of the studyTimepoint: 1.Baseline, 7th Day, 15th Day, 21st Day &30th Day 2.Baseline and 30th Day 3.Baseline and 30th Day | — |
Countries
India
Contacts
Public ContactShekhar Gupta
D2L Clinical Solutions Pvt Ltd.
Outcome results
None listed