Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial
Ischemic stroke (IS) is characterized by high morbidity and high mortality. The integration of Traditional Chinese medicine (TCM) and western medicine has shown promising benefits in relieving symptoms, promoting neurological recovery, and improving the quality of life of patients with IS. In TCM, Q...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2020-06-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2020.00892/full |
| _version_ | 1828190522090455040 |
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| author | Yu Wang Ling Zhang Yuan-jiang Pan Wei Fu Shu-wei Huang Bin Xu Li-ping Dou Qun Hou Chang Li Li Yu Hui-fen Zhou Jie-hong Yang Hai-tong Wan |
| author_facet | Yu Wang Ling Zhang Yuan-jiang Pan Wei Fu Shu-wei Huang Bin Xu Li-ping Dou Qun Hou Chang Li Li Yu Hui-fen Zhou Jie-hong Yang Hai-tong Wan |
| author_sort | Yu Wang |
| collection | DOAJ |
| description | Ischemic stroke (IS) is characterized by high morbidity and high mortality. The integration of Traditional Chinese medicine (TCM) and western medicine has shown promising benefits in relieving symptoms, promoting neurological recovery, and improving the quality of life of patients with IS. In TCM, Qi-deficiency along with blood-stasis (QDBS) syndrome is one of the common types of IS that is treated by invigorating Qi and activating blood circulation. In TCM theory, improving the corresponding degree of prescription–syndrome correlation (PSC) is helpful to improve clinical efficacy. In this study, we intend to use similar prescriptions that invigorate Qi and activate blood circulation: Buyang Huanwu granules (BHG), Naoxintong capsules (NXTC), and Yangyin Tongnao granules (YTG). The goal is to evaluate their level of PSC inpatients with IS with QDBS syndrome and find relevant biomarkers to provide an objective basis for precise treatment of TCM and improve the clinical therapeutic effects. A multicenter, randomized, double-blinded, and placebo-controlled intervention trial will be conducted in IS patients with QDBS syndrome, followed by an add-on of Chinese patent medicine. A total of 160 subjects will be randomly assigned to the BHG, NXTC, YTG, and placebo groups in a 1:2:1:1 allocation ratio. All subjects will undergo 28 days of treatment and then followed for another 180 days. The primary outcome is the changes in the National Institutes of Health Stroke Scale score after 28 days of medication. The secondary outcomes include the modified Rankin scale score, activity of daily living scale score, and TCM symptom score. Data will be analyzed in accordance with a predefined statistical analysis plan. Ethical approval of this trial has been granted by the Research Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (ID: 2017-Y-004-02). Written informed consent of patients will be required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR1800015189), and the results will be disseminated to the public through peer-reviewed journals and academic conferences. |
| first_indexed | 2024-04-12T08:23:56Z |
| format | Article |
| id | doaj.art-08c5a281ccaa43f19b550e9616d06085 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T08:23:56Z |
| publishDate | 2020-06-01 |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-08c5a281ccaa43f19b550e9616d060852022-12-22T03:40:28ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122020-06-011110.3389/fphar.2020.00892524938Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled TrialYu Wang0Ling Zhang1Yuan-jiang Pan2Wei Fu3Shu-wei Huang4Bin Xu5Li-ping Dou6Qun Hou7Chang Li8Li Yu9Hui-fen Zhou10Jie-hong Yang11Hai-tong Wan12Institute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, ChinaInstitute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Chemistry, Zhejiang University, Hangzhou, ChinaDepartment of Cardiac-Cerebral Diseases, Yinchuan Cardiac-Cerebral Treatment Internet Hospital, Yinchuan, ChinaDepartment of Cardiovascular Diseases, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Neurology, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Cardiovascular Diseases, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Neurology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaInstitute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, ChinaInstitute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, ChinaInstitute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, ChinaBasic Medical and Public Health College, Zhejiang Chinese Medical University, Hangzhou, ChinaInstitute of Cardio-cerebrovascular Disease, Zhejiang Chinese Medical University, Hangzhou, ChinaIschemic stroke (IS) is characterized by high morbidity and high mortality. The integration of Traditional Chinese medicine (TCM) and western medicine has shown promising benefits in relieving symptoms, promoting neurological recovery, and improving the quality of life of patients with IS. In TCM, Qi-deficiency along with blood-stasis (QDBS) syndrome is one of the common types of IS that is treated by invigorating Qi and activating blood circulation. In TCM theory, improving the corresponding degree of prescription–syndrome correlation (PSC) is helpful to improve clinical efficacy. In this study, we intend to use similar prescriptions that invigorate Qi and activate blood circulation: Buyang Huanwu granules (BHG), Naoxintong capsules (NXTC), and Yangyin Tongnao granules (YTG). The goal is to evaluate their level of PSC inpatients with IS with QDBS syndrome and find relevant biomarkers to provide an objective basis for precise treatment of TCM and improve the clinical therapeutic effects. A multicenter, randomized, double-blinded, and placebo-controlled intervention trial will be conducted in IS patients with QDBS syndrome, followed by an add-on of Chinese patent medicine. A total of 160 subjects will be randomly assigned to the BHG, NXTC, YTG, and placebo groups in a 1:2:1:1 allocation ratio. All subjects will undergo 28 days of treatment and then followed for another 180 days. The primary outcome is the changes in the National Institutes of Health Stroke Scale score after 28 days of medication. The secondary outcomes include the modified Rankin scale score, activity of daily living scale score, and TCM symptom score. Data will be analyzed in accordance with a predefined statistical analysis plan. Ethical approval of this trial has been granted by the Research Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (ID: 2017-Y-004-02). Written informed consent of patients will be required. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR1800015189), and the results will be disseminated to the public through peer-reviewed journals and academic conferences.https://www.frontiersin.org/article/10.3389/fphar.2020.00892/fulltraditional Chinese medicineprescription–syndrome correlationQi deficiency and blood stasis syndromeischemic strokestudy protocol |
| spellingShingle | Yu Wang Ling Zhang Yuan-jiang Pan Wei Fu Shu-wei Huang Bin Xu Li-ping Dou Qun Hou Chang Li Li Yu Hui-fen Zhou Jie-hong Yang Hai-tong Wan Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial Frontiers in Pharmacology traditional Chinese medicine prescription–syndrome correlation Qi deficiency and blood stasis syndrome ischemic stroke study protocol |
| title | Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial |
| title_full | Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial |
| title_fullStr | Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial |
| title_short | Investigation of Invigorating Qi and Activating Blood Circulation Prescriptions in Treating Qi Deficiency and Blood Stasis Syndrome of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial |
| title_sort | investigation of invigorating qi and activating blood circulation prescriptions in treating qi deficiency and blood stasis syndrome of ischemic stroke patients study protocol for a randomized controlled trial |
| topic | traditional Chinese medicine prescription–syndrome correlation Qi deficiency and blood stasis syndrome ischemic stroke study protocol |
| url | https://www.frontiersin.org/article/10.3389/fphar.2020.00892/full |
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