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

NCT06551298 | Not Yet Recruiting

• 1 other identifier: 032
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemias

Keywords

Hyperlipidemias; Tibetan tea; Atorvastatin

Outcome Measures

Primary Outcomes (2)

• TC

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

  4 weeks

• TG

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

  4 weeks

Study Arms (3)

Experimental group

EXPERIMENTAL

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

Other: Menggongzi Tibetan Tea Special Drink

Positive control group

ACTIVE COMPARATOR

Atorvastatin Calcium Tablets (20mg, qn)+Low fat diet

Drug: Atorvastatin Calcium 20Mg Tab

Negative control group

OTHER

Low fat diet

Other: Low fat diet

Interventions

Menggongzi Tibetan Tea Special Drink OTHER

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

Experimental group

Atorvastatin Calcium 20Mg Tab DRUG

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

Positive control group

Low fat diet OTHER

Low fat diet

Negative control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Individuals with a family history of primary hypercholesterolemia;
• Active liver disease or unexplained persistent elevation of serum transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2-fold upper limit of normal (ULN));
• The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2;
• Creatine kinase (CK)\>3 times ULN;
• Individuals who have used any lipid-lowering drugs within the past month; 10）Individuals allergic to Tibetan tea and atorvastatin calcium;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (15)

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MeSH Terms

Conditions

Hyperlipidemias

Interventions

Atorvastatin; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Chunjian Li, PHD

CONTACT

13701465229; lijay@njmu.edu.cn

mengying Dong, MD

CONTACT

13182825232; 1746411347@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: October 1, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)