A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionized Water (HAIW) in healthy participants
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. Safety related lab parameters including CBC, LFT, RFT, Blood Sugar, ECG, Sr. Electrolytes
研究概览
简要总结
It is a randomized, controlled,double blind clinical study to evaluateuse of Hydron Alkaline Ionized Water (HAIW) in healthy participants. The study will be carried out in 1 centre in India. As per computer generated randomization list, subjects will be randomized either to HAIW Group or Packaged Drinking water Group in 1:1 ratio. During stay in the hospital subjects will be asked to consume at least 3 Liters of HAIW or PDW apart from the water used for food and refreshments. The primary objectives of the study will be to assesssafety related lab parameters including CBC, LFT, RFT, Blood Sugar, ECG, Sr. Electrolytes and safety by evaluation of adverse events based on clinical signs and symptoms. The secondary objectives of the study will be to assess changes in digestion related symptoms (appetite, digestion, bowel habits), change in urine output and symptoms, change in sleep quality, change in overall quality of life, change in level of Energy, level of stamina and physical strength, change in daytime fatigue using Fatigue Severity Scale (FSS), change in Global evaluation for overall change on CGI-I Scale by physician and subjects, and change in global assessment of overall safety by physician and subjects on screening visit (Day -3), baseline visit (Day 0), every day till next 7 days
Summary of Results:
The study concludes that HAIW was well tolerated by all the study
participants without causing any adverse effects. All safety related laboratory
parameters showed no significant change over a period of 7 days. HAIW
showed significant improvement in digestive system like appetite, digestion
and bowel habits. There was a significant improvement in sleep quality and
freshness after waking up with the use of HAIW as compared to PDW. All the
vital parameters remained within normal range in both the groups throughout
the study period and showed non-significant change between HAIW and
PDW. Urine parameters showed non-significant change from baseline to 7
days and between the groups.
The study concludes that HAIW can be safely without causing any adverse
effects and improves function like digestion and sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Male and Female participants in the age group of 21-40 Years
- •Subjects of female gender or non-pregnant, non-lactating females.
- •A urine pregnancy test is required for all female subjects of childbearing potential unless female subject has had a hysterectomy, tubal ligation, or is greater than 2 years postmenopausal.
- •Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •Known cases of any Severe and Chronic disease.
- •Known subject of any active malignancy.
- •Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization.
- •Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •Subjects with Diabetes and Hypertension
- •Subjects using any other investigational drug within 1 month prior to recruitment.
- •Known hypersensitivity to alkaline water
- •Pregnant and Lactating females.
- •Subjects currently participating in any other Clinical study.
- •Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
结局指标
主要结局
1. Safety related lab parameters including CBC, LFT, RFT, Blood Sugar, ECG, Sr. Electrolytes
时间窗: Screening visit (Day -3), Baseline visit (Day 0), Every day till next 7 days
2. Safety by evaluation of adverse events based on clinical signs and symptoms
时间窗: Screening visit (Day -3), Baseline visit (Day 0), Every day till next 7 days
次要结局
- 1. Changes in digestion related symptoms (appetite, digestion, bowel habits)(2. Change in urine output and symptoms)
研究者
Dr Vineet Kumar Malhotra
Shivam Multi-speciality and Accident Care Centre Pvt. Ltd