Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial
Background: the use of statin to lower blood cholesterol is often associated with bothersome adverse effects such as myopathy and liver dysfunction. NC120 is herbal lipid lowering drug containing red yeast rice (RYR) extract, guggulipid, and chromium picolinate, and expected to have better safety pr...
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Interna Publishing
2019-05-01
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| Series: | Acta Medica Indonesiana |
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| Online Access: | https://www.actamedindones.org/index.php/ijim/article/view/980 |
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| author | Nafrialdi Nafrialdi Johannes Hudyono Frans D Suyatna Arini Setiawati |
| author_facet | Nafrialdi Nafrialdi Johannes Hudyono Frans D Suyatna Arini Setiawati |
| author_sort | Nafrialdi Nafrialdi |
| collection | DOAJ |
| description | Background: the use of statin to lower blood cholesterol is often associated with bothersome adverse effects such as myopathy and liver dysfunction. NC120 is herbal lipid lowering drug containing red yeast rice (RYR) extract, guggulipid, and chromium picolinate, and expected to have better safety profile. The aim of this study was to evaluate the efficacy and safety profiles of NC120 in lowering blood lipid. Methods: this was a double blind randomized clinical trial comparing NC120 with placebo in subjects with hypercholesterolemia. Two capsules of NC120 or placebo were administered twice a day for 28 days. Blood total-cholesterol, LDL-cholesterol, and triglyceride were measured on day-0, day-7, and day-28. Unpaired t-test was used to compare study parameter between groups, and one-way ANOVA was used to compare within group. Results: 25 subjects received NC120 and 24 subjects received placebo. Significant decrease of total cholesterol and LDL-cholesterol were observed since day-7 in NC120 group, while the changes in placebo group were not significant at all time of observation. No significant decrease of triglyceride was observed in NC120 group and in placebo group. Side effects were minor and comparable between the two groups. Conclusion: NC120 is effective in reducing total cholesterol and LDL-cholesterol, but not triglyceride. This drug shows a good safety profile, and thus can be considered for patients who can not tolerate statin drugs. |
| format | Article |
| id | doaj-art-195bbfb1fe4443a89fbf0773eba39cef |
| institution | Kabale University |
| issn | 0125-9326 2338-2732 |
| language | English |
| publishDate | 2019-05-01 |
| publisher | Interna Publishing |
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| series | Acta Medica Indonesiana |
| spelling | doaj-art-195bbfb1fe4443a89fbf0773eba39cef2025-08-20T03:51:53ZengInterna PublishingActa Medica Indonesiana0125-93262338-27322019-05-01511Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled TrialNafrialdi Nafrialdi0Johannes Hudyono1Frans D Suyatna2Arini Setiawati3Dept. of Pharmacology, Faculty of Medicine Universitas Indonesia –Cipto Mangunkusumo Hospital, Jakarta, IndonesiaClinical Research Supporting Unit, Faculty of Medicine, Universitas Indonesia1. Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia 2.Clinical Research Supporting Unit, Faculty of Medicine, Universitas Indonesia1. Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia 2. Clinical Research Supporting Unit, Faculty of Medicine, Universitas IndonesiaBackground: the use of statin to lower blood cholesterol is often associated with bothersome adverse effects such as myopathy and liver dysfunction. NC120 is herbal lipid lowering drug containing red yeast rice (RYR) extract, guggulipid, and chromium picolinate, and expected to have better safety profile. The aim of this study was to evaluate the efficacy and safety profiles of NC120 in lowering blood lipid. Methods: this was a double blind randomized clinical trial comparing NC120 with placebo in subjects with hypercholesterolemia. Two capsules of NC120 or placebo were administered twice a day for 28 days. Blood total-cholesterol, LDL-cholesterol, and triglyceride were measured on day-0, day-7, and day-28. Unpaired t-test was used to compare study parameter between groups, and one-way ANOVA was used to compare within group. Results: 25 subjects received NC120 and 24 subjects received placebo. Significant decrease of total cholesterol and LDL-cholesterol were observed since day-7 in NC120 group, while the changes in placebo group were not significant at all time of observation. No significant decrease of triglyceride was observed in NC120 group and in placebo group. Side effects were minor and comparable between the two groups. Conclusion: NC120 is effective in reducing total cholesterol and LDL-cholesterol, but not triglyceride. This drug shows a good safety profile, and thus can be considered for patients who can not tolerate statin drugs.https://www.actamedindones.org/index.php/ijim/article/view/980Nutraforcholesterolred yeast riceguggulipid |
| spellingShingle | Nafrialdi Nafrialdi Johannes Hudyono Frans D Suyatna Arini Setiawati Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial Acta Medica Indonesiana Nutrafor cholesterol red yeast rice guggulipid |
| title | Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial |
| title_full | Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial |
| title_fullStr | Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial |
| title_full_unstemmed | Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial |
| title_short | Safety and Efficacy of NC120 for Improving Lipid Profile: A Double Blind Randomized Controlled Trial |
| title_sort | safety and efficacy of nc120 for improving lipid profile a double blind randomized controlled trial |
| topic | Nutrafor cholesterol red yeast rice guggulipid |
| url | https://www.actamedindones.org/index.php/ijim/article/view/980 |
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