Evaluation of efficacy and safety of Immunity Booster Capsules as an Immunity Booster in Adults: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total leucocyte count (TLC), absolute lymphocyte count (ALC) and lymphocyte percentage documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)
研究概览
简要总结
Bacterial and Viral infections affect all ages and are the leading cause of morbidity and mortality across the world. Viruses are probably the most common cause of infectious disease acquired within indoor environments and both virus and bacteria have considerable impact on human health, ranging from severe life-threatening illnesses to relatively mild and self-limiting or asymptomatic diseases. This may depend on the immune status of the patient and their ability to clear infection as well as the characteristics of the pathogen. Increasing numbers of people who have reduced immunity to infection, where the consequences of infection can be much more serious than healthy individuals. In general, bacteria and viruses causing respiratory and gastrointestinal diseases spread rapidly in the community and cause considerable morbidity.
Despite the advances in medical and science technology, there are few conventional medications or vaccines for most of the infection causing bacteria and viruses. However, the microorganisms gaining resistance to the existing drugs which is making the treatment difficult. Because of this, most of the researchers are focusing on nutritional supplements for natural immune boosting. A healthy immune system prevents the incidence of various infectious diseases. There are numerous vitamins and trace elements which are essential for normal functioning of the immune system. Additionally, several herbals, probiotics and micronutrients also have shown potency for treatment and prevention of infections. Moreover, several nutraceuticals and probiotics have also shown a complementary role in enhancing immune responses. Therefore, the purpose of study is to investigate the effect of nutraceuticals as an immune booster for maintaining a healthy immune system in adult population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged 18 years and above.
- •Subjects with general immunodeficiency as determined by the study investigator.
- •Subjects who are prone to seasonal immunity associated illnesses as determined by the study investigator
- •Subjects willing to provide informed written consent.
排除标准
- •Pregnant, planning to become pregnant or breastfeeding women.
- •Subjects with significant medical/surgical condition which requires long-term treatment.
- •Subjects who are currently being treated with other immunostimulant drugs.
- •Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
- •Alcohol or substance abuse
- •Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
- •Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
结局指标
主要结局
Total leucocyte count (TLC), absolute lymphocyte count (ALC) and lymphocyte percentage documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)
时间窗: baseline and day 30
次要结局
- Serum immunoglobulins (IgM, IgG and IgA) and natural killer cells levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)(baseline and day 30)
- Episodes of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons).(baseline, day 15 and day 30)
- Severity of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)(baseline, day 15 and day 30)
- Number of subjects having immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)(baseline, day 15 and day 30)
- Duration of immunity associated illness (allergy and infection) documented in the CRF at baseline, day 15 and day 30 (values within the group and between the groups comparisons)(baseline, day 15 and day 30)