| CTRI Number |
CTRI/2024/07/071708 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of Efficacy and Safety of Magnesium Glycinate in the Management of Selected Inflammatory Diseases |
|
Scientific Title of Study
|
A Randomimized, double blind, Parallel group study to assess safety and efficacy of Magnesium Glycinate in the management of selected inflammatory disease like Asthma, COPD, Rheumatoid Arthritis and Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M.Maneesh Kumar Reddy |
| Designation |
Associate Professor |
| Affiliation |
Mahathi College of Pharmacy |
| Address |
Department of Pharmacy Practice, Mahathi College of Pharmacy, CTM Cross Roads, Madanapalle
Chittoor
ANDHRA PRADESH
517319
India |
| Phone |
9490709063 |
| Fax |
|
| Email |
maneesh.maddirevula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MG Rajanandh |
| Designation |
Professor |
| Affiliation |
SRM College of Pharmacy |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRMIST, Kattanklathur, Chennai
Chennai
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr MG Rajanandh |
| Designation |
Professor |
| Affiliation |
SRM College of Pharmacy |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRMIST, Kattankulathur, Chennai
Chennai
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgr@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahathi college of Pharmacy, Madanapalle, Annamayya District, Andhrapradesh, India, 517319 |
|
|
Primary Sponsor
|
| Name |
M Maneesh Kumar Reddy |
| Address |
Associate Professor, Mahathi college of Pharmacy, Madanapalle, Annamayya District, Andhrapradesh, India, 517319 |
| Type of Sponsor |
Other [SELF ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Maneesh Kumar Reddy |
Arogyavaram Medical Center, Madanapalle |
Room No. 104, Department of Pharmacy Practice, Arogyavaram Medical Center, Sanitorium, Madanapalle, Annamayya District, Andhrapradesh.
Chittoor
ANDHRA PRADESH |
9490709063
maneesh.maddirevula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHATHI COLLEGE OF PHARMACY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J454||Moderate persistent asthma, (3) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (4) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Standard therapy + Magnesium Glycinate |
400mg - oral - once daily for 1 year |
| Comparator Agent |
standard therapy + Placebo |
400mg - oral - once daily - for one year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with hypomagnesemia (serum magnesium level below 1.6mg/dl)
Age (above 18 years)
Individuals willing to participate in study
Patients on standard therapy managing their inflammatory disorders (Asthma, COPD, Rheumatoid Arthritis and Osteoarthritis)
Both sex
|
|
| ExclusionCriteria |
| Details |
Known allergy to the any of the drug investigated
Currently using any magnesium related products
Having any psychiatric illness
Administering drugs that affect ADME of investigation product
Presence of alcohol or drug dependence
Evidence of renal or hepatic impairment
Pregnant and lactating women
Participation in any other clinical trials
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
C-Reactive Protein,
Inflammatory Markers (TNF Alpha, IL-6, IL-10),
Disease Activity Score |
0 month, 3 month, 6 month, 9 month, 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Serum Magnesium,
Quality of Life,
Medication Adherence,
Adverse Drug Reactions,
FEV1/FVC (Asthma & COPD),
Ligamentous Laxity (Osteoarthritis),
Rheumatoid Factor (Rheumatoid Arthritis)
|
0 month, 3 month, 6 month, 9 month, 12 month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study titled "Efficacy and Safety of Magnesium Glycinate as an Add-On Therapy in the Management of Selected Inflammatory Disorders" investigates the potential benefits of magnesium glycinate as an adjunct treatment for chronic inflammatory conditions such as asthma, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis (RA), and osteoarthritis (OA). Conducted under the supervision of Dr. M.G. Rajanandh and presented by Maddirevula Maneesh Kumar Reddy, the research explores the hypothesis that magnesium supplementation can reduce inflammation and improve patient outcomes. Background and RationaleMagnesium deficiency is linked to increased inflammation due to various biological mechanisms, including activation of immune cells and inflammatory pathways. Chronic inflammatory conditions like asthma, COPD, RA, and OA are exacerbated by such deficiencies. Traditional anti-inflammatory medications often lead to severe side effects, emphasizing the need for safer alternatives. Magnesium, crucial for numerous enzymatic processes, nerve function, heart health, and immune response, is a promising candidate due to its role in reducing systemic inflammation.
|