To study the effects of herbal supplement on reduction in stress and enhancement of immunity in healthy population.

Completed

Brief Summary: The purpose of the study is to investigate reduction in stress levels and the improvement in and general immunity in 120 healthy subjects. In the proposed randomized, double-blind, placebo-controlled study, the lower and higher dose of beverage containing herbal blend will be compared against placebo to evaluate safety, 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 IgG levels, and improvement using Hamilton Anxiety Scale (HAM-A) Scale. Other secondary parameters include Cohenâ€™s Perceived Stress Scale Questionnaire (PSSQ), estimation of natural killer cells (NK) Cells, and safety assessments for the subjects.

Recruitment & Eligibility

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.

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.).

Primary Outcome Measures

Name	Time	Method
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	1.Baseline,7th,15th,21st,& 30th Day \| 2.Baseline, 30th, & 60th day
2.To assess the Efficacy of Beverage 3(formulation 3A and formulation 3B) for its Immunity properties through Serum IgG Test	1.Baseline,7th,15th,21st,& 30th Day \| 2.Baseline, 30th, & 60th day

Secondary Outcome Measures

Name	Time	Method
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

Locations (2): National Institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
St. Johns Research Institute
🇮🇳
Bangalore, KARNATAKA, India
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Pawan Kumar Godatwar
Principal investigator
8005841032
pgodatwar@gmail.com