Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Introduction: Coronary artery calcification (CAC) is closely associated with adverse cardiovascular events in patients with stable coronary heart disease (CHD). Effective treatments specifically targeting CAC progression are still lacking, representing an urgent clinical need. Traditional Chinese me...
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Elsevier
2025-06-01
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| Series: | Pharmacological Research - Modern Chinese Medicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667142525000430 |
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| author | Qian Xu Wenting Wang Xiaochen Wang Wenwu Liu Chuyao Qi Mengmeng Zhu Jing Cui Yiwen Li Yanfei Liu Yue Liu |
| author_facet | Qian Xu Wenting Wang Xiaochen Wang Wenwu Liu Chuyao Qi Mengmeng Zhu Jing Cui Yiwen Li Yanfei Liu Yue Liu |
| author_sort | Qian Xu |
| collection | DOAJ |
| description | Introduction: Coronary artery calcification (CAC) is closely associated with adverse cardiovascular events in patients with stable coronary heart disease (CHD). Effective treatments specifically targeting CAC progression are still lacking, representing an urgent clinical need. Traditional Chinese medicine (TCM) has been widely used in the prevention and treatment of CHD, playing a crucial synergistic role. This study aims to evaluate the efficacy and safety of DLTM formula in preventing CAC progression in patients with stable CHD. Methods: This multicenter, randomized, double-blind, placebo-controlled trial will be conducted at Xiyuan Hospital of China Academy of Chinese Medical Sciences, the Second Hospital of Anhui Medical University, and Suzhou Hospital of Traditional Chinese Medicine. A total of 194 eligible participants are expected to be recruited. Participants will be randomly assigned to the DLTM formula group and the placebo control group in a 1:1 ratio. All participants will receive a 12-week pharmacological intervention and will be followed up for 9 months after completing the medication. The primary outcome measure is the coronary artery calcium volume score, and the secondary outcome measures include the Agatston score, coronary plaque burden, and the frequency and intensity of angina attacks. Adverse events will be closely monitored throughout the trial. The trial is registered at the International Traditional Medicine Clinical Trial Registry (ITMCTR2024000060). Results: The trial will assess changes in coronary imaging parameters, clinical symptom assessments, and safety profiles, providing objective evidence for the DLTM formula's efficacy and safety. Discussion: This study is expected to fill the clinical treatment gap for CAC, clarify the therapeutic value of the DLTM formula, and offer a novel strategy for managing stable CHD. |
| format | Article |
| id | doaj-art-f6f6d1ce16fc4e239284e1b0a9a6df8a |
| institution | DOAJ |
| issn | 2667-1425 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Pharmacological Research - Modern Chinese Medicine |
| spelling | doaj-art-f6f6d1ce16fc4e239284e1b0a9a6df8a2025-08-20T02:39:37ZengElsevierPharmacological Research - Modern Chinese Medicine2667-14252025-06-011510061410.1016/j.prmcm.2025.100614Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trialQian Xu0Wenting Wang1Xiaochen Wang2Wenwu Liu3Chuyao Qi4Mengmeng Zhu5Jing Cui6Yiwen Li7Yanfei Liu8Yue Liu9National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100091, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100091, ChinaCardiovascular disease department, The Second Affiliated Hospital of Anhui Medical University, Heifei, Anhui province,ChinaSuzhou hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Suzhou, Jiangsu province, ChinaCardiovascular disease department, The Second Affiliated Hospital of Anhui Medical University, Heifei, Anhui province,ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100091, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100091, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100091, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100091, China; The Second Department of Gerontology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, ChinaNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing 100091, China; Suzhou hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Suzhou, Jiangsu province, China; Corresponding author at: National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, China.Introduction: Coronary artery calcification (CAC) is closely associated with adverse cardiovascular events in patients with stable coronary heart disease (CHD). Effective treatments specifically targeting CAC progression are still lacking, representing an urgent clinical need. Traditional Chinese medicine (TCM) has been widely used in the prevention and treatment of CHD, playing a crucial synergistic role. This study aims to evaluate the efficacy and safety of DLTM formula in preventing CAC progression in patients with stable CHD. Methods: This multicenter, randomized, double-blind, placebo-controlled trial will be conducted at Xiyuan Hospital of China Academy of Chinese Medical Sciences, the Second Hospital of Anhui Medical University, and Suzhou Hospital of Traditional Chinese Medicine. A total of 194 eligible participants are expected to be recruited. Participants will be randomly assigned to the DLTM formula group and the placebo control group in a 1:1 ratio. All participants will receive a 12-week pharmacological intervention and will be followed up for 9 months after completing the medication. The primary outcome measure is the coronary artery calcium volume score, and the secondary outcome measures include the Agatston score, coronary plaque burden, and the frequency and intensity of angina attacks. Adverse events will be closely monitored throughout the trial. The trial is registered at the International Traditional Medicine Clinical Trial Registry (ITMCTR2024000060). Results: The trial will assess changes in coronary imaging parameters, clinical symptom assessments, and safety profiles, providing objective evidence for the DLTM formula's efficacy and safety. Discussion: This study is expected to fill the clinical treatment gap for CAC, clarify the therapeutic value of the DLTM formula, and offer a novel strategy for managing stable CHD.http://www.sciencedirect.com/science/article/pii/S2667142525000430Traditional Chinese medicine compoundDLTM formulaCoronary artery calcificationRandomized controlled trialTraditional Chinese medicineStudy protocol |
| spellingShingle | Qian Xu Wenting Wang Xiaochen Wang Wenwu Liu Chuyao Qi Mengmeng Zhu Jing Cui Yiwen Li Yanfei Liu Yue Liu Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial Pharmacological Research - Modern Chinese Medicine Traditional Chinese medicine compound DLTM formula Coronary artery calcification Randomized controlled trial Traditional Chinese medicine Study protocol |
| title | Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full | Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_fullStr | Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_short | Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_sort | efficacy and safety of traditional chinese medicine compound dltm formula on cac progression in patients with stable chd study protocol for a multicenter randomized double blind placebo controlled trial |
| topic | Traditional Chinese medicine compound DLTM formula Coronary artery calcification Randomized controlled trial Traditional Chinese medicine Study protocol |
| url | http://www.sciencedirect.com/science/article/pii/S2667142525000430 |
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