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| Efficacy and Safety of Herbal Medicine Yun-Cai Tea in the Treatment of Hyperlipidemia: A Double-Blind Placebo-Controlled Clinical Trial |
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| KeyWord:yun-cai tea, low-density lipoprotein-cholesterol, total cholesterol, triglycerides |
| Author Name | Affiliation | E-mail | | Chien-Ying Lee, Min-Chien Yu, Chun-Che Lin | | | | Hung-Che Shih | 1. Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, China
2. Department of Pharmacy, Chung Shan Medical University Hospital, Taichung, Taiwan, China
| shj525@csmu.edu.tw |
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| Abstract: |
| Objective: Animal studies have demonstrated a lipid-modulating effect of yun-cai tea. However, little is known about the lipid-lowering effect in humans.The aim of this study was to evaluate the lipid lowering effects and safety of yun-cai tea in patients with elevated lipid levels in a human clinical trial. Methods: This was a 12-week, randomly assigned, parallel-group, double-blind, and placebo-controlled pilot clinical study. Sixty primary hyperlipidemia patients were included and randomly assigned to the yun-cai tea group (30 patients) and the placebo group (30 patients), for 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint was changes in plasma low-density lipoprotein-cholesterol (LDL-C) at 8 weeks. The secondary endpoints included total cholesterol (TC) and triglycerides (TG). Results: Our results revealed no statistically significant differences in LDL-C and TC between the two groups. Despite the lack of a statistically significant difference in the level of TG between the two groups, a declining trend was noted. A significant reduction of TG was observed in the yun-cai tea group at week 8, compared to baseline (P=0.048). The incidence of stomach discomfort, gastroesophageal reflux, diarrhea, and constipation was slightly higher in the yun-cai tea group. No other significant adverse events were found. Conclusions: It is unlikely that yun-cai tea used had a blood lipid reduction effect. Further larger scale clinical trials with a longer duration and larger dose are necessary. |
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