Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol
IntroductionThe Qu-shi-hua-tan decoction (QSHTD), formulated by academician Chen Keji, is an empirical decoction for coronary heart disease (CHD). We conducted a randomized controlled trial to assess the effectiveness and safety of QSHTD in managing angina after coronary revascularization (AACR) in...
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Frontiers Media S.A.
2025-04-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1512385/full |
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| author | Wenjing Xu Jingwei Wen Xijiu Li Xiaoqing Li Yan Zhang Weihui Lu Weihui Lu Weihui Lu Weihui Lu |
| author_facet | Wenjing Xu Jingwei Wen Xijiu Li Xiaoqing Li Yan Zhang Weihui Lu Weihui Lu Weihui Lu Weihui Lu |
| author_sort | Wenjing Xu |
| collection | DOAJ |
| description | IntroductionThe Qu-shi-hua-tan decoction (QSHTD), formulated by academician Chen Keji, is an empirical decoction for coronary heart disease (CHD). We conducted a randomized controlled trial to assess the effectiveness and safety of QSHTD in managing angina after coronary revascularization (AACR) in CHD patients.Methods and designThis double-blind randomized controlled trial will be conducted at Guangdong Provincial Hospital of Traditional Chinese Medicine. We will allocate 98 qualified participants to either the experimental or control group in a 1:1 ratio through random selection. The experimental group will be given standard care along with QSHTD, whereas the control group will receive standard care and a placebo. The study will span 26 weeks, consisting of a 2-week initial phase, a 12-week intervention phase, and a 12-week monitoring phase. The main outcome measure will be myocardial blood flow (MBF) assessed using adenosine stress real-time myocardial perfusion echocardiography (RTMPE). The secondary outcomes will be Canadian Cardiovascular Sociation Classification, Seattle Angina Questionnaire, Traditional Chinese Medicine (TCM) symptom evaluation; and major adverse cardiac events (MACE).DiscussionThis study seeks to deliver compelling proof of the superior methodological and reporting standards of QSHTD's effectiveness and safety within AACR treatment.
Clinical Trial RegistrationChinese Clinical Trial Registration Center [www.chictr.org.cn]. The trial was registered on November 26, 2020 [ChiCTR2000040270]. |
| format | Article |
| id | doaj-art-93853d31213f4e1ca319299c39dd905d |
| institution | Kabale University |
| issn | 2297-055X |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj-art-93853d31213f4e1ca319299c39dd905d2025-08-20T03:53:39ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2025-04-011210.3389/fcvm.2025.15123851512385Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocolWenjing Xu0Jingwei Wen1Xijiu Li2Xiaoqing Li3Yan Zhang4Weihui Lu5Weihui Lu6Weihui Lu7Weihui Lu8The Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaState Key Laboratory of Traditional Chinese Medicine Syndrome, Guangdong Provincial Hospital of Chinese MedicineGuangzhou University of Chinese Medicine, Guangzhou, ChinaChinese Medicine Guangdong Laboratory, Guangzhou, Guangdong, ChinaIntroductionThe Qu-shi-hua-tan decoction (QSHTD), formulated by academician Chen Keji, is an empirical decoction for coronary heart disease (CHD). We conducted a randomized controlled trial to assess the effectiveness and safety of QSHTD in managing angina after coronary revascularization (AACR) in CHD patients.Methods and designThis double-blind randomized controlled trial will be conducted at Guangdong Provincial Hospital of Traditional Chinese Medicine. We will allocate 98 qualified participants to either the experimental or control group in a 1:1 ratio through random selection. The experimental group will be given standard care along with QSHTD, whereas the control group will receive standard care and a placebo. The study will span 26 weeks, consisting of a 2-week initial phase, a 12-week intervention phase, and a 12-week monitoring phase. The main outcome measure will be myocardial blood flow (MBF) assessed using adenosine stress real-time myocardial perfusion echocardiography (RTMPE). The secondary outcomes will be Canadian Cardiovascular Sociation Classification, Seattle Angina Questionnaire, Traditional Chinese Medicine (TCM) symptom evaluation; and major adverse cardiac events (MACE).DiscussionThis study seeks to deliver compelling proof of the superior methodological and reporting standards of QSHTD's effectiveness and safety within AACR treatment. Clinical Trial RegistrationChinese Clinical Trial Registration Center [www.chictr.org.cn]. The trial was registered on November 26, 2020 [ChiCTR2000040270].https://www.frontiersin.org/articles/10.3389/fcvm.2025.1512385/fullprotocolrandomized controlled trialTraditional Chinese Medicinecoronary heart diseasequ-shi-hua-tan decoction |
| spellingShingle | Wenjing Xu Jingwei Wen Xijiu Li Xiaoqing Li Yan Zhang Weihui Lu Weihui Lu Weihui Lu Weihui Lu Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol Frontiers in Cardiovascular Medicine protocol randomized controlled trial Traditional Chinese Medicine coronary heart disease qu-shi-hua-tan decoction |
| title | Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol |
| title_full | Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol |
| title_fullStr | Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol |
| title_full_unstemmed | Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol |
| title_short | Qu-shi-hua-tan decoction's efficacy and safety for patients with angina following coronary revascularization: a randomized, double-blind, placebo-controlled trial study protocol |
| title_sort | qu shi hua tan decoction s efficacy and safety for patients with angina following coronary revascularization a randomized double blind placebo controlled trial study protocol |
| topic | protocol randomized controlled trial Traditional Chinese Medicine coronary heart disease qu-shi-hua-tan decoction |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1512385/full |
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