HypertriglyceridemiaNCT03649269
PC-300 Tea Effect on Triglyceride Levels
A study testing PC-300 tea. and Bezafibrate in people with Hypertriglyceridemia, run by Ciprés Grupo Médico CGM SC.
Trial summary
Herbal medicine represents an alternative for treating dyslipidemia. The aim of this project was to evaluate the PC-300 tea (Eryngium heterophyllum egelm + Amphipterygium adstringens) against hypertriglyceridemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- PC-300 tea. and Bezafibrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertriglyceridemia, aged >18 years and with an educational level at least of primary school.
Who cannot join
- Patients with hepatic disease and those missing an appointment during the study.
About this study
Official title: Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels
Herbal medicine represents an alternative for treating dyslipidemia. The aim of this project was to evaluate the PC-300 tea (Eryngium heterophyllum egelm + Amphipterygium adstringens) against hypertriglyceridemia.
Baseline samples of serum total cholesterol and triglycerides were obtained and measured again after 1 month of treatment with the following two alternatives: 1) PC-300, one cup half an hour before eating, and 2) bezafibrate 200 mg/d.
Read the detailed description
It was a descriptive, prospective, longitudinal, and comparative clinical study developed at Ciprés Grupo Médico S.C. (CGM), Toluca, Mexico, from January 2014 to December 2014.
Patients with hypertriglyceridemia were invited to participate in the study. Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.
Patients were measured (m) and weighed (kg) (Obi, México). Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared. Blood pressure was measured with a calibrated sphygmomanometer (Welch Allyn, USA) after 5 min of rest.
All of the patients were given a low lipid diet. Calculated kcal were based on ideal weight minus 200 kcal/day if overweight.
Results were expressed as mean ± Standard deviation (SD). Differences between initial vs. final values were compared with the Mann-Whitney U test. The normality hypothesis was tested using the Kolmogorov-Smirnov test. A p value of <0.05 was considered significant. All tests were performed with the SPSS ver. 23 statistical software program.
- Conditions
- Hypertriglyceridemia
- Being tested
- PC-300 tea., Bezafibrate
- Keywords
- Eryngium heterophyllum, Amphipterygium adstringens, tea
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-300 tea.Dietary supplement
Also called Herbal tea
Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.
BezafibrateDrug
Also called Bezalip
Patients were prescribed 200 mg/day at night.
| Study group | Role | What they receive |
|---|---|---|
| PC-300 tea | Experimental | Patients that received the Eryngium heterophyllum + Amphipterygium adstringens tea, one cup half an hour before eating. Receives: Dietary Supplement: PC-300 tea. |
| Bezafibrate | Active comparator | Patients that received fibrate (bezafibrate) 200 mg/day. Receives: Drug: Bezafibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides serum levels.
The triglycerides serum levels were measured at the recruiting moment and after one month..
Measured: One month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Jan 2014
- Primary completion30 Nov 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciprés Grupo Médico CGM SC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Mendieta Zerón, PhD., Principal investigator, Ciprés Grupo Médico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649269
- Sponsor's protocol ID
- 2014/02
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: With this first study researcher are not planning to share the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels
- ClinicalTrials.gov ID
- NCT03649269
- Acronym / sponsor ID
- 2014/02
- Conditions
- Hypertriglyceridemia
- Keywords
- Eryngium heterophyllum, Amphipterygium adstringens, tea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ciprés Grupo Médico CGM SCUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 28 Aug 2018 (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.
Herbal medicine represents an alternative for treating dyslipidemia. The aim of this project was to evaluate the PC-300 tea (Eryngium heterophyllum egelm + Amphipterygium adstringens) against hypertriglyceridemia.
Baseline samples of serum total cholesterol and triglycerides were obtained and measured again after 1 month of treatment with the following two alternatives: 1) PC-300, one cup half an hour before eating, and 2) bezafibrate 200 mg/d.
Detailed description
It was a descriptive, prospective, longitudinal, and comparative clinical study developed at Ciprés Grupo Médico S.C. (CGM), Toluca, Mexico, from January 2014 to December 2014.
Patients with hypertriglyceridemia were invited to participate in the study. Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.
Patients were measured (m) and weighed (kg) (Obi, México). Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared. Blood pressure was measured with a calibrated sphygmomanometer (Welch Allyn, USA) after 5 min of rest.
All of the patients were given a low lipid diet. Calculated kcal were based on ideal weight minus 200 kcal/day if overweight.
Results were expressed as mean ± Standard deviation (SD). Differences between initial vs. final values were compared with the Mann-Whitney U test. The normality hypothesis was tested using the Kolmogorov-Smirnov test. A p value of <0.05 was considered significant. All tests were performed with the SPSS ver. 23 statistical software program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.
| Arm | Type | Receives |
|---|---|---|
| PC-300 tea | Experimental | Dietary Supplement: PC-300 tea.Patients that received the Eryngium heterophyllum + Amphipterygium adstringens tea, one cup half an hour before eating. |
| Bezafibrate | Active comparator | Drug: BezafibratePatients that received fibrate (bezafibrate) 200 mg/day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hypertriglyceridemia, aged >18 years and with an educational level at least of primary school.
Key exclusion criteria (1 listed)
- Patients with hepatic disease and those missing an appointment during the study.
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 |
|---|---|---|
| PC-300 tea.Also: Herbal teaPatients had to drink one cup of the tea half an hour before breakfast, main meal and dinner. | Dietary supplement | PC-300 tea |
| BezafibrateAlso: BezalipPatients were prescribed 200 mg/day at night. | Drug | Bezafibrate |
Primary outcome
Triglycerides serum levels.
Time frame: One month.
The triglycerides serum levels were measured at the recruiting moment and after one month..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: Undecided. With this first study researcher are not planning to share the IPD.
Related trials for Hypertriglyceridemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
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. This study is not recruiting at the moment.
Hugo Mendieta Zerón, PhD. principal investigator
Ciprés Grupo Médico
Questions about this trial
What is this clinical trial studying?
A study testing PC-300 tea. and Bezafibrate in people with Hypertriglyceridemia, run by Ciprés Grupo Médico CGM SC.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides serum levels. (time frame: One month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2018; AzTrials last refreshed its copy on 28 Oct 2026.