A Randomized, Open label, Multi-centric, Comparative, Prospective, Interventional, Clinical Study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in Health & Immunity Related Parameters
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Comparative assessment of immunity fitness by measuring immunity parameters on self-reported scales
研究概览
简要总结
It is a randomized, open label, multi-centric, comparative, prospective, interventional, clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in Health & Immunity Related Parameters. The study will be carried out in 4 to 5 centers across India. As per computer generated randomization list, subjects will be randomized either to HAIW Group or Packaged Drinking Water in 1:1 ratio. Subject will be asked to consume either HAIW or Packaged Drinking water as and even required for 90 days. The primary objective of the study will be to assess immunity fitness by measuring immunity parameters on self-reported scales. The secondary objectives of the study will be to assess difference of absent days in office or workplace due to infections or allergies, number of participants for absent days in office or workplace due to infections or allergies, change in energy levels, physical fitness, strength and stamina, number of participants having change in energy levels, physical fitness, strength and stamina, quality of life as assessed using WHO QOL BREF, Physician’s and Subject’s Global evaluation for overall Change on CGI-I Scale and incidence of adverse events, serious adverse events and vitals on Screening/ Baseline Visit (Day 0), Day 30, Day 60, Day 90
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy, Male or Female subjects
- •Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
排除标准
- •Pregnant and Lactating females
- •Uncontrolled cases of Diabetes and Hypertension
- •Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
- •Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
- •Subjects taking steroid treatment and or any kind of immunosuppressive therapy
- •Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.
- •Subjects having allergy to alkaline water
- •Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
结局指标
主要结局
Comparative assessment of immunity fitness by measuring immunity parameters on self-reported scales
时间窗: Screening/ Baseline Visit (Day 0), Day 30, Day 60, Day 90
次要结局
- 1. Comparative assessment of difference of absent days in office or workplace due to infections or allergies(2. Comparative assessment of number of participants for absent days in office or workplace due to infections or allergies)
研究者
Dr Nilesh Londhe
Nirvikar Ayurveda Hospital