跳至主要内容
临床试验/CTRI/2024/07/071708
CTRI/2024/07/071708尚未招募不适用

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

M Maneesh Kumar Reddy1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
C-Reactive Protein,

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

C-Reactive Protein,

时间窗: 0 month, 3 month, 6 month, 9 month, 12 month

Inflammatory Markers (TNF Alpha, IL-6, IL-10),

时间窗: 0 month, 3 month, 6 month, 9 month, 12 month

Disease Activity Score

时间窗: 0 month, 3 month, 6 month, 9 month, 12 month

次要结局

  • Serum Magnesium,(Quality of Life,)

研究者

发起方
M Maneesh Kumar Reddy
申办方类型
Other [SELF ]
责任方
Principal Investigator
主要研究者

M.Maneesh Kumar Reddy

Mahathi College of Pharmacy

研究点 (1)

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