"Perfect Heartio" Drink and Cardiovascular Health

NCT07048158 | Recruiting

• 1 other identifier: TPH001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Lipid Metabolism Disorders

Keywords

Complementary and alternative medicine; Herbal Medicine

Outcome Measures

Primary Outcomes (4)

• Lipid profile

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

  Week 0, 4, 8 and 12

• Cardiac inflammatory levels

  C-reactive protein

  Week 0, 4, 8 and 12

• Cardiac injury levels

  Creatine kinase

  Week 0, 4, 8 and 12

• Cardiac remodelling status

  Matrix metalloproteinases-9 (MMP-9)

  Week 0, 4, 8 and 12

Secondary Outcomes (2)

• Quality of Life of subject

  Week 0, 4, 8 and 12

• Self-perceived health status

  Week 0, 4, 8 and 12

Study Arms (1)

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.

Dietary Supplement: Perfect Heartio Drink

Interventions

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.

Perfect Heartion Drink Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Perfect Series Sdn Bhd: lead
• UCSI University: collaborator

Study Sites (1)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (2)

• Cooper F. How to publish a winning newsletter. Health Care Can. 1979 Sep;21(9):41-2. No abstract available.

  PMID: 10243891 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chung Keat Tan, PhD

  UCSI University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Keat Tan, PhD

CONTACT

0175063305; cktan@ucsiuniversity.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be required to consume Perfect Heartio (PH) drink for 12 weeks, at the dosage of 15g twice daily. Compliance form will be given to monitor the compliance of subject. Assessment will be conducted at week 0, 4, 8 and 12. 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.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: April 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon publication of the study outcomes, for a time frame of 5 years
• Access Criteria: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after de-identification will be shared upon reasonable request. Additional documents including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following publication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.

Locations

MY (1)