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Clinical Trial on the Efficacy and Safety of Ganoderma Spore Powder in Treating Hyperlipidemia of the Type with Phlegm-Turbidity Obstruction

Clinical Trial on the Efficacy and Safety of Ganoderma Spore Powder in Treating Hyperlipidemia of the Type with Phlegm-Turbidity Obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000329
Enrollment
Unknown
Registered
2025-02-18
Start date
2022-10-11
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Hyperlipidemia of the Type with Phlegm-Turbidity Obstruction

Interventions

Treatment Group:Atorvastatin Calcium 20mg.qn combined with Ganoderma Spore Powder 2g per dose BID (twice daily)
Control Group:Atorvastatin Calcium 20mg.qn combined with placebo

Sponsors

Zhejiang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for hyperlipidemia as outlined in the "Chinese Guidelines for the Prevention and Treatment of Dyslipidemia in Adults" (2016 revised edition). Under normal dietary conditions the lipid test report shows one or more of the following conditions: total cholesterol (TC) = 6.2 mmol/L triglycerides (TG) = 2.3 mmol/L high-density lipoprotein (HDL-C) = 0.91 mmol/L low-density lipoprotein (LDL-C) = 3.4 mmol/L. Additionally the condition should be classified as hypercholesterolemia or mixed hyperlipidemia. 2. The traditional Chinese medicine (TCM) syndrome type is phlegm-dampness obstruction. 3. Age = 40 years old. 4. If the patient has previously taken lipid-lowering medications they should have stopped the medication for more than 4 weeks and their lipid levels should still meet the diagnostic criteria. 5. Voluntary participation in this research project with signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with simple hypertriglyceridemia or low high-density lipoprotein cholesterol (HDL-C); 2. Patients with critical conditions such as acute coronary syndrome acute cerebrovascular accident hypertensive crisis hypertensive encephalopathy or diabetic ketoacidosis; 3. Patients with end-stage diseases such as malignant tumors and an expected lifespan of less than 6 months; 4. Patients with hepatic or renal dysfunction: AST or ALT levels exceeding twice the upper limit of normal active liver disease or chronic kidney disease (CKD) stage 3 or above; 5. Pregnant women postpartum women lactating women or women planning for pregnancy; 6. Patients with poor follow-up compliance or severe emotional or mental disorders that hinder cooperation; 7. Patients participating in other clinical studies that may influence the outcomes of this research.

Design outcomes

Primary

MeasureTime frame
Lipid Profile Test;TCM Syndrome Score;blood lipid;

Secondary

MeasureTime frame
Blood Viscosity Indicators;Electrocardiogram;Kidney Function;Complete Blood Count (CBC);Echocardiography;intestinal flora;Liver Function;Visual diagnosis;Liver Ultrasound;Blood Viscosity;Oral Microbiota;

Countries

China

Contacts

Public ContactMinchun Yang

Zhejiang Hospital

zjyyymc@163.com15336522560

Outcome results

None listed

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