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NCT Number: NCT07048158

"Perfect Heartio" Drink and Cardiovascular Health

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location status: Recruiting

Location contact

Eugenie Sin Sing Tan, PhD

CONTACT

[email protected]

0168924008

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Perfect Heartio Drink

Dietary Supplement

Perfect Heartio (PH) drink is a nutritional drink composed of diluted herbal extracts of TCM, including ginger, Glycyrrhiza uralensis, Alternanthera sessilis, Panax notoginseng, Red date, Codonopsis pilosula, Ligusticum chuanxiong, Astragalus membranaceus.

Primary outcomes

  1. Lipid profile

    Time frame: Week 0, 4, 8 and 12

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

  2. Cardiac inflammatory levels

    Time frame: Week 0, 4, 8 and 12

    C-reactive protein

  3. Cardiac injury levels

    Time frame: Week 0, 4, 8 and 12

    Creatine kinase

  4. Cardiac remodelling status

    Time frame: Week 0, 4, 8 and 12

    Matrix metalloproteinases-9 (MMP-9)

Secondary outcomes

  1. Quality of Life of subject

    Time frame: Week 0, 4, 8 and 12

    Scale title: HeartQoL (Heart-related Quality of Life questionnaire). Minimum and maximum values: ranges from 0 to 3. Interpretation: Higher scores indicate better health-related quality of life. The global score is the mean of all answered items (14 total: 10 physical and 4 emotional).

  2. Self-perceived health status

    Time frame: Week 0, 4, 8 and 12

    Scale title: Visual Analogue Scale (VAS). Minimum and maximum values: 0 to 10. Interpretation: Higher scores indicate better cardiovascular health. In this context, a score of 0 represents the worst imaginable cardiovascular health, while a score of 10 represents the best imaginable cardiovascular health as perceived by the patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Chung Keat Tan, PhD

CONTACT

[email protected]

0175063305

Sponsors and collaborators

Lead sponsor

The Perfect Series Sdn Bhd

Industry

Collaborators

  • UCSI University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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