Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

About 179 million people die from cardiovascular disease each year, accounting for approximately 31% of global deaths. It is expected that this number will exceed 236 million by 2030, and the economic burden caused by this disease is increasing year by year.At present, the number of people suffering from cardiovascular diseases in China is as high as 330 million, and the mortality rate accounts for more than 40% of the total deaths caused by diseases, and is in a continuous upward trend.Long term dyslipidemia will increase the incidence rate and mortality of atherosclerotic diseases.Tibetan tea contains catechins, caffeine, amino acids, vitamins, and various mineral components, which have significant effects in reducing cholesterol, improving carbohydrate metabolism, lowering blood sugar, losing weight, softening human blood vessels, and other aspects.At present, there are no research reports on the lipid-lowering effect of Mongolian Gongzi Tibetan Tea Special Drink, and most studies on the lipid-lowering effect of Tibetan Tea are animal experiments or clinical observational studies. Therefore, this study intends to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Mongolian Gongzi Tibetan Tea Special Drink in patients with hyperlipidemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meets the diagnostic criteria for hyperlipidemia: total cholesterol (TC) ≥ 6.20mmol/L, triglycerides (TG) ≥ 2.30 mmol/L. If one of the above blood lipid indicators is abnormal, it can be included in this study;

Age ≥ 18 years old, gender not limited;

The patient is willing to follow the research protocol and sign an informed consent form.

Disqualifiers

Atherosclerotic cardiovascular disease (ASCVD) patients;

Diabetes patients;

Severe hypercholesterolemia (TC>8 mmol/L or LDL-C ≥ 4.9 mmol/L) or severe hypertriglyceridemia (TG ≥ 5.6 mmol/L);

Secondary hyperlipidemia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Menggongzi Tibetan Tea Special Drink

    Other intervention

    Menggongzi Tibetan Tea Special Drink (50ml/time, taken after breakfast and lunch)+Low fat diet

  • Atorvastatin Calcium 20Mg Tab

    Drug

    Atorvastatin Calcium Tablets (20mg, qn)+Low Fat Diet

  • Low fat diet

    Other intervention

    Low fat diet

Treatment groups

129 Participants
are divided into 3 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Positive control groupActive comparator 1 intervention
Group C: Negative control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

TC

Comparison of TC levels between Tibetan tea and a simple low-fat diet compared to baseline

Time frame
4 weeks
2

TG

Comparison of TG levels between Tibetan tea and atorvastatin compared to baseline

Time frame
4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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