"Perfect Heartio" Drink and Cardiovascular Health

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Dietary supplement Perfect Heartio Drink
  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 outcome measures

• Lipid profile [Time frame: Week 0, 4, 8 and 12]
• Cardiac inflammatory levels [Time frame: Week 0, 4, 8 and 12]
• Cardiac injury levels [Time frame: Week 0, 4, 8 and 12]
• Cardiac remodelling status [Time frame: Week 0, 4, 8 and 12]

Secondary outcome measures (2)

• Quality of Life of subject [Time frame: Week 0, 4, 8 and 12]
• Self-perceived health status [Time frame: Week 0, 4, 8 and 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Malaysia · 1 center

• UCSI University — Cheras

Publications

• Kumari S, Samara M, Ampadi Ramachandran R, Gosh S, George H, Wang R, Pesavento RP, Mathew MT. A Review on Saliva-Based Health Diagnostics: Biomarker Selection and Future Directions. Biomed Mater Devices. 2023 Jun 6:1-18. doi: 10.1007/s44174-023-00090-z. Online ahead of print. PMID 37363139
• Ling Lee W, Chinna K, Sumintono B. Psychometrics assessment of HeartQoL questionnaire: A Rasch analysis. Eur J Prev Cardiol. 2021 Oct 13;28(12):e1-e5. doi: 10.1177/2047487320902322. Epub 2020 Feb 4. No abstract available. PMID 34647582

Identifiers

NCT: NCT07048158 · TPH001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗