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Study on the intervention of Rosa roxburghii stock solution in patients with hyperlipidemia

Study on the intervention of Rosa roxburghii stock solution in patients with hyperlipidemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080730
Enrollment
Unknown
Registered
2024-02-05
Start date
2023-02-28
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated hyperlipidemia

Interventions

treatment group:take Rosa roxburghii stock solution
Blank group:None

Sponsors

The Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
26 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chinese adults aged =18 and =65 on the date of signing the informed consent, regardless of gender; 2. Fasting 5.2 mmol/L < serum total cholesterol (TC) < 7.2 mmol/L and/or 1.7 mmol/L < serum triglyceride (TG) < 5.6 mmol/L and/or 3.4 mmol/L < low density lipoprotein cholesterol (LDL-C) < 4.9 Patients with mmol/L and/or high-density lipoprotein cholesterol (HDL-C) < 1.0 mmol/L; 3. Understand the research procedures and methods, participate in this experiment voluntarily, and sign informed consent in person.

Exclusion criteria

Exclusion criteria: 1.Patients with diseases of the cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, immune system, nervous/psychiatric system, blood and lymphatic system, skeletal muscle system, and so on. Patients with diseases of chronic gastritis and gastric ulcer, who are taking alkaline drugs such as sodium bicarbonate and magnesium oxide that are not suitable for drinking acidic solutions; 2.Patients diagnosed with nephrotic syndrome, severe liver disease, Cushing's syndrome, thyroid insufficiency and other diseases that significantly affecting serum of lipid levels; 3.Patients with infectious diseases in the active stage that are not suitable for participating in the clinical trial according to the evaluating of researcher; 4.Patients are diagnosed with malignant tumors within 5 years before screening (excluding the cured malignant tumors that have not observed recurrence in the last 5 years, completely resected basal and squamous cell skin cancers, and carcinoma in situ); 5.Subjects participated in other clinical trials of drug interventions within 2 weeks before screening (excluding subjects screening fail); 6.Subjects with history of drug abuse before screening; 7.Subjects with history of major surgery within 3 months before screening or planning major surgery during the study; 8.Subjects with history of long-term (=7 days) and (or) repeated (cumulative use of =3 times) systemic use of glucocorticoids, hypoglycemic drugs (including but not limited to biguanides, alpha-glucosidase inhibitors, glucagon-like peptide-1 receptor agonists, etc.), antihypertensive drugs (including but not limited to ß-receptor blockers, thiazide diuretics, etc.), antibiotics (including but not limited to anti-tuberculosis drugs, antibacterial drugs, etc.) and antitumor drugs within 3 months before screening (excluding local use, such as intra-articular, nasal, inhalation, skin external use, and etc.); 9.Subjects with history of using weight-loss drugs or surgery that caused to weight instability within 2 months before screening; 10.Subjects with history of using lipid-lowering drugs (including but not limited to statins, bates, cholesterol absorption inhibitors, niacin) or health products with lipid-lowering effects within 4 weeks before screening; 11.Subjects are allergic to any ingredient in Roxburghii and Roxburghii yeast active stock; 12.Subjects with positive test results of hepatitis B surface antigen (HBsAg), hepatitis Be antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV), treponema pallidum antibody (TP-Ab); 13.Male or female subjects does not consent to use effective contraception during the clinical trial; 14.Subjects are pregnant or lactating women; 15.Subjects are not suitable for this clinical study according to the investigator evaluating.

Design outcomes

Primary

MeasureTime frame
Total cholesterol;Triglyceride;HDL-C;

Secondary

MeasureTime frame
LDL-C;Lp(a);LDL/HDL;

Countries

China

Contacts

Public ContactHe Yan

The Affiliated Hospital of Guizhou Medical University

physicianheyan@126.com+86 189 8405 8185

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026