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临床试验/CTRI/2024/10/075448
CTRI/2024/10/075448尚未招募不适用

Nutraceuticals Supplement for Chronic inflammatory Disorders – Nutrigenomics and Metagenomic Landscape

Department of Health Research Ministry of Health and Family Welfare Government of India1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月24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
40
试验地点
1
主要终点
The primary outcome of this study is to assess the efficacy of the nutraceutical mixed polyherbal powder in managing chronic inflammatory disorders. Reductions in the symptoms indicate improvements in disease severity and control, reflecting the effectiveness of the nutraceutical intervention in mitigating chronic inflammation.

研究概览

简要总结

Chronic inflammatorydiseases, encompassing conditions like rheumatoid arthritis, diabetes, atherosclerosis,non-alcoholic fatty liver disease cancer, etc, present a substantial challengeto healthcare systems globally due to their persistent inflammation affectingvarious organs and systems in the body. Standard treatments, often involvingimmunosuppressive drugs, may not adequately control symptoms and can carryrisks of adverse effects.

In this study, we proposea novel approach to managing chronic inflammatory disorders by developing amixed polyherbal nutraceutical powder. Leveraging the synergistic effects ofnatural compounds, our formulation aims to address underlying inflammatory processeswhile promoting overall health and well-being. Notably, our research considersthe role of gut microbiota in chronic inflammation, recognizing theirsignificant influence on immune function and inflammatory responses.

Preliminary toxicity andpreclinical studies have demonstrated the safety and effectiveness of ournutraceutical supplement, facilitating further investigations into its efficacyin chronic inflammatory disorders in human. Through the dissemination ofknowledge on functional food concepts and healthy living, we aim to empowerindividuals with tools for self-care and disease management.

By considering theintricate interplay between nutrition, gut microbiota, and inflammation, ourstudy seeks to advance understanding and treatment options for chronicinflammatory disorders, offering promising avenues for safer and moresustainable management strategies. Through these efforts, we envision a futurewhere nutraceutical interventions play a pivotal role in promoting immunehealth and mitigating chronic inflammation, ultimately improving the quality oflife for patients worldwide

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Individuals with no conventional biomarkers for diabetes, atherosclerosis and arthritis shall be selected from the population belonging to the Thiruvananthapuram district between the age group of 18-60 years after obtaining informed consent.
  • Anthropological data and blood samples shall be collected based on routine laboratory procedure.

排除标准

  • Individuals not belonging to the specified age group, without informed consent shall be excluded from the study.
  • Individuals with diagnosed with contagious diseases, chronic illness, cancer or chemotherapy patients shall be excluded from the study.
  • Additionally, pregnant and lactating women shall be excluded from the study.

结局指标

主要结局

The primary outcome of this study is to assess the efficacy of the nutraceutical mixed polyherbal powder in managing chronic inflammatory disorders. Reductions in the symptoms indicate improvements in disease severity and control, reflecting the effectiveness of the nutraceutical intervention in mitigating chronic inflammation.

时间窗: Baseline and 30, 60, 90 and 120 days

次要结局

  • To assess anti-inflammatory effect after the trial period(baseline and 30, 60, 90 and 120 days)

研究者

发起方
Department of Health Research Ministry of Health and Family Welfare Government of India
申办方类型
Government funding agency

研究点 (1)

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