FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/03/012487 [Registered on: 12/03/2018] Trial Registered Prospectively
Last Modified On: 17/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effects of Hydrogen Rich Water on Risk Factors of Heart Disease and Diabetes. 
Scientific Title of Study   Effects of Hydronen Magnesium Tablets on Cardiometabolic Risk Factors and Inflammation in Subjects with Metabolic Syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R B Singh 
Designation  Director Research, 
Affiliation  Halberg Hospital and research Institute 
Address  Department of Medicine, Division of Research, Room 1, Civil Lines,Opp.Wilsonia College, Moradabad (UP)
Department of Medicine,Division of Research,Room 1.
Moradabad
UTTAR PRADESH
244001
India 
Phone  9997794102  
Fax    
Email  rbs@tsimtsoum.net  
 
Details of Contact Person
Scientific Query
 
Name  Dr R B Singh 
Designation  Director Research, 
Affiliation  Halberg Hospital and research Institute 
Address  Civil Lines,Opp.Wilsonia College, Moradabad (UP)
Department of Medicine, Division of Research, Room 1.
Moradabad
UTTAR PRADESH
244001
India 
Phone  9997794102  
Fax    
Email  rbs@tsimtsoum.net  
 
Details of Contact Person
Public Query
 
Name  Dr R B Singh 
Designation  Director Research, 
Affiliation  Halberg Hospital and research Institute 
Address  Civil Lines,Opp.Wilsonia College, Moradabad (UP)
department of Medicine, Division of research, Room 1.
Moradabad
UTTAR PRADESH
244001
India 
Phone  9997794102  
Fax    
Email  rbs@tsimtsoum.net  
 
Source of Monetary or Material Support  
President, Natural Wellness Now Health Products Inc. #106 555 Foster Ave, Coquitlam BC, V3J 0B6 Canada. Email alextarnava@gmail.com 
 
Primary Sponsor  
Name  Natural Wellness Now Health Products Inc 
Address  Natural Wellness Now Health Products Inc. #106 555 Foster Ave, Coquitlam BC, V3J 0B6 Canada. Email alextarnava@gmail.com 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
International College of Nutrition  Civil Lines,Opp.Wilsonia College,Moradabad (UP)244001 
 
Countries of Recruitment     India
Slovakia  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R B Singh  Halberg Hospital and Research Institute  Department of Medicine, Outdoor Room 1,Civil Lines, Opp. Wilsonia College,(UP) Civil Lines, Opp. wilsonia College
Moradabad
UTTAR PRADESH 
9997794102

rbs@tsimtsoum.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Halberg Hospital and Research Institute Ethic Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Metabolic Syndrome 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hydrogen-manesium tablets  Active ingredient: Hydrogen-Rich Water (HRW). HRW is made with a H2-producing tablet that contains non-ionic metallic magnesium with organic acids (malic and tartaric). IT also contains small amount of dextrose (200 mg), and the lubricant PRUV (Sodium Stearyl Fumarate), which is a commonly used lubricating agent for tablets and other products. There are no indications that it is toxic, and it is approved as GRAS by the FDA. The active magnesium reacts with water to produce molecular hydrogen (H2) and magnesium hydroxide [Mg(OH)2] according to the reaction: Mg + 2H2O -- H2 + Mg(OH)2. The magnesium hydroxide is then neutralized by the organic acids leaving magnesium ions and their conjugate bases (Mg(OH)2 + malic acid/tartaric acid -- Mg2+ + malate + tartrate). The amount of Mg in each tablet is 80mg, which is well below the daily reference intake (DRI), and upper limit, thus avoiding any adverse events from magnesium ingestion. (https://ods.od.nih.gov/factsheets/Magnesium-HealthProfessional/).and inactive placebo tabs. 
Comparator Agent  Placebo tablets  Identical placebo tablets with inactive agent 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria: Adults aged 30-60 years without recent AMI or stroke, with any of the three markers of metabolic syndrome; prehypertension, prediabetes and central obesity or dyslipidemia.
Criteria of diagnosis. Prehypertension would be considered in presence of systolic BP 130-139 mm HG and diastolic 85-89 mm Hg. Pre-diabetes would be considered in presence of fasting blood glucose 110-125 mg/dl. Central obesity would be considered in presence of waste circumference of 100 mm in women and 90 mm among men.
 
 
ExclusionCriteria 
Details  Exclusion criteria: cancer, chronic dysentery, HIV 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary: Effects of h2 magnesium tablets on various markers of metabolic syndrome; blood pressures, blood glucose and central obesity,triglycerides and HDL cholesterol as well as hsCRP along with parameters of oxidative stress; TBARS,MDA, diene conjugates  Baseline
After 4 weeks
After 12 weeks
After 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary: effects on IL-6,IL-1,TNF-alpha,IL-10, NFkbeta, MMPs,leptin, cortisol  Baseline and after 12 or 24 weeks,if funds available  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/05/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Design of study would be presented at Cardiovascular Scicences congress, Bratislava May 2018 
Brief Summary   Please let me know how to paste the summary?
Randomized,double blind controlled trial with with molecular hydrogen in metabolic syndrome.
Follow up 12 or 24 weeks
Parameters; blood lipids, hsCRP, blood glucose, TBARS,MDA,diene conjugate

Similar study is planned at Bratislava in Slovakia 
 
Close