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临床试验/NCT07048158
NCT07048158招募中不适用

Beneficial Effects of "Perfect Heartio" Drink in Improving Cardiovascular Health

The Perfect Series Sdn Bhd2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
55
试验地点
2
主要终点
Lipid profile

研究概览

简要总结

Noncommunicable diseases (NCDs) such as type 2 diabetes (T2D) and cardiovascular disease (CVD) account for more deaths globally than any other condition. In 2018, the WHO reported that NCDs accounted for 71% of global deaths. They also showed that low- and middle-income countries are disproportionately affected by NCDs, accounting for 85% of NCD-related deaths among individuals aged 30-69 y. Among NCDs, CVD is the leading and fourth-leading causes of death, accounting for 19.5 million deaths worldwide in 2018. Furthermore, despite increasing global awareness, the prevalence of these conditions continues to increase at alarming rates. Deaths from CVD are expected to reach 23.6 million annually by 2030 from 17.6 million deaths in 2016. The underlying aetiology of these conditions is complex, as they can be influenced by several environmental, genetic, and behavioural factors. However, diet and nutrition play a particularly important role in these conditions, especially in the context of the double burden of malnutrition facing many low- and middle-income countries.

详细描述

Traditional Chinese Medicine (TCM), one of the intriguing features of traditional Chinese culture, has a history of more than 2,000 years, with both unique theories and rich experience. Because of the lack of objective and quantitative evaluation criteria, TCM is complementary or alternative medicine in most Western countries. However, in China, more than 71.2% of patients who have experienced Western medicine, TCM, and integrative medicine (both Western medicine and TCM) preferred the integrative approach, and 18.7% chose TCM as their favourite. Moreover, TCM is increasingly welcomed in many developed countries, such as Australia and the United States. Importantly, patients who used more types of TCM tended to use much less Western medicine recommended by current guidelines. Recent review also highlighted the potential use of TCM as a complementary and alternative approach to the primary and secondary prevention of cardiovascular disease. Perfect Heartio (PH) is a nutritional drink composed of mainly diluted herbal extracts of TCM, including ginger, Glycyrrhiza uralensis, Alternanthera sessilis, Panax notoginseng, red date, Codonopsis pilosula, Ligusticum chuanxiong, Astragalus membranaceus. Broad pharmacological properties of ginger and its bioactive components have been reported, suggesting its potential use in preventing CVD. Glycyrrhiza uralensis stands out for its exceptional therapeutic potential, particularly in enhancing cardiac muscle regeneration, and slowing muscle aging. Alternanthera sessilis has been showed to prevent cardiovascular and liver diseases. Panax notoginseng improve angiogenesis. Red date exerts anti-adipogenicity effects and enhancing endothelial function. Codonopsis pilosula improves the functional state of the cardiovascular system and mitigating the onset and progression of CVD. Ligusticum chuanxiong has been showed to promote blood circulation and remove blood stasis. Astragalus membranaceus also showed to improve cardiovascular function, protect myocardial cells, and increase coronary blood flow.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •General healthy subjects during enrolment
  • •Age 18 and above
  • •Willing to comply with interventional plan and comes to do follow up
  • •Willing to gives consent

排除标准

  • •Use nonsteroidal anti-inflammatory drugs (NSAIDs) more than once a week during enrolment
  • •Use of anticoagulants or corticosteroids
  • •Use of individual supplements of vitamin A, E, or beta carotene more than once a week during enrolment
  • •Renal failure or dialysis, cirrhosis, other serious conditions that precluded participation
  • •No previous history of cancer (except nonmelanoma skin cancer)
  • •Pregnant or lactating woman

研究组 & 干预措施

Perfect Heartion Drink Interventional Arm

Experimental

Subjects will be required to consume PH drink for 12 weeks, at the dosage of 15g twice daily. Compliance form will be given to monitor the compliance of subject.

干预措施: Perfect Heartio Drink (Dietary Supplement)

结局指标

主要结局

Lipid profile

时间窗: Week 0, 4, 8 and 12

Total cholesterol levels, Triglycerides levels, LDL- cholesterol levels, HDL-cholesterol levels

Cardiac injury levels

时间窗: Week 0, 4, 8 and 12

Creatine kinase

Lipid profile

时间窗: Week 0, 4, 8 and 12

Total cholesterol levels, Triglycerides levels, LDL- cholesterol levels, HDL-cholesterol levels

Cardiac inflammatory levels

时间窗: Week 0, 4, 8 and 12

C-reactive protein

Cardiac remodelling status

时间窗: Week 0, 4, 8 and 12

Matrix metalloproteinases-9 (MMP-9)

Cardiac inflammatory levels

时间窗: Week 0, 4, 8 and 12

C-reactive protein

Cardiac injury levels

时间窗: Week 0, 4, 8 and 12

Creatine kinase

Cardiac remodelling status

时间窗: Week 0, 4, 8 and 12

Matrix metalloproteinases-9 (MMP-9)

次要结局

  • Quality of Life of subject(Week 0, 4, 8 and 12)
  • Self-perceived health status(Week 0, 4, 8 and 12)
  • Quality of Life of subject(Week 0, 4, 8 and 12)
  • Self-perceived health status(Week 0, 4, 8 and 12)

研究者

发起方
The Perfect Series Sdn Bhd
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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"Perfect Heartio" Drink and Cardiovascular Health | 临床试验