An Interventional, Randomized, Parallel Group, Placebo Controlled, Three Arm Clinical Study of Beverage Formulations (Formulation 2-A and Formulation 2-B) to assess improvement in immunity and management of general health in Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1.To assess the efficacy of beverage 2 (formulation 2A and formulation 2B) for the Immune-supportive properties through serum IgG test.
研究概览
简要总结
The purpose of the study is to investigate the improvement in physical energy and immunity in approximately 120 healthy subjects. In the proposed randomized, double-blind, placebo-controlled study, the lower (base) and higher dose of beverage containing herbal blend will be compared against placebo for evaluating 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 overall improvement using Quality of Life (QoL) Scale. Other secondary parameters include estimation of natural killer cells (NK) Cells, Profile of Mood scale, Perceived Stress Scale questionnaire, Cohen’s Perceived Stress Scale Questionnaire (PSSQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults Healthy Subjects willing to provide a written Informed Consent 2.Age group:
- •45 Years 3.BMI:
- •25 kg/m2 4.No prior history of any allergy 5.Subjects with borderline immunity.
- •IgG levels (600 – 799 mg/dl).
排除标准
- •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.).
结局指标
主要结局
1.To assess the efficacy of beverage 2 (formulation 2A and formulation 2B) for the Immune-supportive properties through serum IgG test.
时间窗: 1.Baseline, 30th Day & 60th Day | 2.Baseline, 7th Day, 15th Day, 21st Day & 30th Day
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.
时间窗: 1.Baseline, 30th Day & 60th Day | 2.Baseline, 7th Day, 15th Day, 21st Day & 30th Day
次要结局
- 1.NK Cells Estimation Test (for 20% of subjects)(2.Profile of mood states (POMS) Scale)