Treatment of hyperlipidemia and carotid atherosclerosis with ShenJu granules
A Randomized, Double-blind, Placebo-controlled Study of ShenJu in the Treatment of Hyperlipidemia Combined With Carotid Atherosclerosis
This study is testing whether ShenJu granules, a traditional Chinese medicine, can help people with high cholesterol and carotid artery disease improve their heart health compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 15 Years to 65 Years |
| Sex | All |
| Sponsor | Guangdong Provincial Hospital of Traditional Chinese Medicine Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06166121 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of ShenJu granules, a traditional Chinese medicine formulation, in treating patients with hyperlipidemia combined with carotid atherosclerosis. The primary outcome measure is pulse wave velocity (PWV), which is an important indicator of cardiovascular health. The study aims to provide evidence for the use of ShenJu granules in managing these conditions, potentially reducing the risk of serious cardiovascular events. Participants will be randomly assigned to receive either ShenJu granules or a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have been diagnosed with hyperlipidemia and carotid atherosclerosis.
Not a fit: Patients with severe liver, kidney, or cardiac insufficiency, as well as those with other serious conditions or who are pregnant, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel and effective option for managing hyperlipidemia and carotid atherosclerosis, potentially reducing the risk of stroke and other cardiovascular diseases.
How similar studies have performed: While traditional Chinese medicine approaches have been explored in various studies, the specific use of ShenJu granules for this combination of conditions is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient has informed consent and signed the informed consent form 2. Age between 18-65 years old 3. Meet the diagnostic criteria for hyperlipidemia and accompanied by carotid arteriosclerosis 4. Meet the diagnostic criteria of TCM wet certificate: refer to the scoring standard of TCM Wet Disease Scale Exclusion Criteria: 1. Severe liver, kidney and cardiac insufficiency 2. Any other serious disease or condition such as: malignant tumor, uncontrolled severe hypertension, diabetic ketoacidosis (acute complication/vascular abnormality), arrhythmia, coagulation abnormalities 3. Have participated in another clinical study within 30 days prior to enrollment or have received a history of randomized ketoacidosis in this study 4. Pregnant women, women preparing to become pregnant and lactating women 5. Patients who are allergic to relevant Chinese medicine ingredients 6. Patients who have had a stent inserted 7. Patients who the investigator determines are not suitable to participate in this study
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
- WangLei — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lei Wang, M.D
- Email: Dr.wanglei@139.com
- Phone: 8620-81887233-3280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.