Health TrialsbyHealthPanel

"Perfect Heartio" Drink and Cardiovascular Health

ConditionsCardiovascular DiseasesLipid Metabolism Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Perfect Series Sdn Bhd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Perfect Heartion Drink Interventional ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lipid profile

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

Time frame
Week 0, 4, 8 and 12
2

Cardiac inflammatory levels

C-reactive protein

Time frame
Week 0, 4, 8 and 12
3

Cardiac injury levels

Creatine kinase

Time frame
Week 0, 4, 8 and 12
4

Cardiac remodelling status

Matrix metalloproteinases-9 (MMP-9)

Time frame
Week 0, 4, 8 and 12

Secondary outcomes

1

Quality of Life of subject

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).

Time frame
Week 0, 4, 8 and 12
2

Self-perceived health status

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.

Time frame
Week 0, 4, 8 and 12

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

UCSI UniversityRecruiting56000, Cheras, Kuala LumpurMalaysiaMalaysia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Perfect Series Sdn Bhd

Lead sponsor

UCSI University

Collaborator

Source ClinicalTrials.gov
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