Cardiovascular DiseasesNCT07048158
"Perfect Heartio" Drink and Cardiovascular Health
A study testing Perfect Heartio Drink in people with Cardiovascular Diseases and Lipid Metabolism Disorders, run by The Perfect Series Sdn Bhd at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Lipid Metabolism Disorders
- What is being tested?
- Perfect Heartio Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
UCSI University
Cheras, Kuala Lumpur, 56000
Eugenie Sin Sing Tan, PhD, 0168924008, eugenietan@ucsiuniversity.edu.my
About this study
Official title: Beneficial Effects of "Perfect Heartio" Drink in Improving 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.
Read the 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.
- Being tested
- Perfect Heartio Drink
- Keywords
- Complementary and alternative medicine, Herbal Medicine
- Medical subject headings
- Cardiovascular Diseases, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfect Heartio DrinkDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Perfect Heartio Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Total cholesterol levels, Triglycerides levels, LDL- cholesterol levels, HDL-cholesterol levels
Measured: Week 0, 4, 8 and 12
Cardiac inflammatory levels
C-reactive protein
Measured: Week 0, 4, 8 and 12
Cardiac injury levels
Creatine kinase
Measured: Week 0, 4, 8 and 12
Cardiac remodelling status
Matrix metalloproteinases-9 (MMP-9)
Measured: Week 0, 4, 8 and 12
Secondary outcomes (2)
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).
Measured: Week 0, 4, 8 and 12
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.
Measured: Week 0, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Perfect Series Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Responsible party
- Sponsor
- Investigators
- Chung Keat Tan, PhD, Principal investigator, UCSI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048158
- Sponsor's protocol ID
- TPH001
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 37363139Ling 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.
PubMed 34647582
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of "Perfect Heartio" Drink in Improving Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07048158
- Acronym / sponsor ID
- TPH001
- Keywords
- Complementary and alternative medicine, Herbal Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The Perfect Series Sdn BhdIndustry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Perfect Heartion Drink Interventional Arm | Experimental | Dietary Supplement: Perfect Heartio DrinkSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perfect Heartio DrinkPerfect 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. | Dietary supplement | Perfect Heartion Drink Interventional Arm |
Primary outcome
Lipid profile
Time frame: Week 0, 4, 8 and 12
Total cholesterol levels, Triglycerides levels, LDL- cholesterol levels, HDL-cholesterol levels
Cardiac inflammatory levels
Time frame: Week 0, 4, 8 and 12
C-reactive protein
Cardiac injury levels
Time frame: Week 0, 4, 8 and 12
Creatine kinase
Cardiac remodelling status
Time frame: Week 0, 4, 8 and 12
Matrix metalloproteinases-9 (MMP-9)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 37363139Kumari 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.
- Background: PubMed 34647582Ling 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chung Keat Tan, PhD principal investigator
UCSI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfect Heartio Drink in people with Cardiovascular Diseases and Lipid Metabolism Disorders, run by The Perfect Series Sdn Bhd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chung Keat Tan, PhD (0175063305, cktan@ucsiuniversity.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: Week 0, 4, 8 and 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.