A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with digestive complains - hyperacidity and functional constipation
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Cohort 1:
研究概览
简要总结
It is a randomized, controlled, double blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with digestive complains - hyperacidity and functional constipation. There will be two cohorts in the study. In cohort 1, healthy subjects with hyperacidity will be enrolled and in cohort 2, healthy subjects with functional constipation will be enrolled. The study will be carried out in 4 to 5 centers in 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 30 days.
Cohort 1:
The primary objective of the study will be to assess change in severity of gastrointestinal symptoms assessed on graded scale. The secondary objectives of the study will be to assess changes in duration, number of episodes and severity of symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, and flatulence, changes in indigestion and appetite, global assessment for overall change by investigator and subject, global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms and assessment of adverse events on baseline visit, day 15 and day 30.
Cohort 2:
The primary objective of the study will be to assess change in frequency of bowel movements. The secondary objectives of the study will be to assess changes in indigestion and appetite on graded scale, changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual maneuvers required & average time spent for bowel evacuation on graded scale, changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension/bloating, acidity on graded scale, global assessment of overall change as per the investigator and subject and assessment of tolerability of study product as per the investigator and subject by assessing Adverse Events/Adverse Drug Reactions on baseline visit, day 15 and day 30.
Results and Observations:
The study concludes that consumption of HAIW showed a significant reduction in symptoms of hyperacidity like acid reflux, pain in abdomen, bloating, burning sensation in the chest and flatulence. These effects were observed within 15 days of starting consuming HAIW and continued further till 30 days. The reduction in these symptoms were found to be significantly better as compared to packaged drinking water. In participants suffering from constipation a non-significant difference was observed between the two groups, HAIW and PDW on bowel habits (frequency, straining etc). In these participants also there was a significantly better improvement in indigestion with the consumption of HAIW as compared to PDW.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Cohort 1:
- •Healthy males and females with any of the mild to moderate symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain, or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, flatulence, indigestion, and appetite.
- •Subjects must be suffering from any of the above symptoms at least from last six months.
- •Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
- •Cohort 2:
- •Male or female subjects presenting with any two symptoms i.e. straining during defecation, lumpy or hard stool, sensation of incomplete evacuation, sensation of anorectal blockade for the last 3 months
- •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
- •Cohort 1:
- •Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart disease, cancer, kidney failure, chronic liver diseases,
- •Subjects having jaundice or any other symptom of active hepatitis
- •Subjects with any other investigational product within 1 month prior to randomization
- •Subject suffering from any other functional dyspepsia, or any other functional gastrointestinal disorder
- •Subjects with diabetes mellitus and hypertension taking regular medications
- •Pregnant and lactating women
- •Subjects with any significant abnormal laboratory parameters
- •Known hypersensitivity to study products
- •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.
- •Cohort 2:
- •Subjects diagnosed with colonic inertia., have recently undergone abdominal surgery, history of anorectal surgery.
- •2.Subjects having other functional gastrointestinal disorders other than Functional constipation
- •Subjects diagnosed with structural abnormalities
- •Subjects with uncontrolled DM and hypertension and Tuberculosis.
- •Known cases of HIV, tuberculosis, hypo and hyperthyroidism
- •Known cases of renal or liver dysfunction.
- •Subjects diagnosed with neurological
- •Subjects on chronic medication greater than 60 days and or who are on medications known to cause constipation.
- •Pregnant or lactating females
- •Subjects allergic to Hydron Alkaline Ionised Water (HAIW) or packaged drinking water 11.
结局指标
主要结局
Cohort 1:
时间窗: Baseline visit, day 15 and day 30
Change in severity of gastrointestinal symptoms assessed on graded scale
时间窗: Baseline visit, day 15 and day 30
Cohort 2:
时间窗: Baseline visit, day 15 and day 30
Change in frequency of bowel movements
时间窗: Baseline visit, day 15 and day 30
次要结局
- Cohort 1:(1. Changes in duration, number of episodes and severity of symptoms on graded scale)
研究者
Dr Ksheetij Kothari
Shivam Multispecialty & Accident Care Centre Pvt. Ltd.