| 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
|
|
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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |