Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial
Abstract Background Numerous pre-clinical studies showed that Qingda granule (QDG) was effective in treating hypertension. This study aims to evaluate the efficacy and safety of QDG in reducing blood pressure among patients with grade 1 hypertension at low-medium risk. Methods The study is designed...
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-07006-0 |
| _version_ | 1797958529713176576 |
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| author | Lin-zi Long Jian-feng Chu Hua Qu Qiao-ning Yang Yan Lu Chang-geng Fu Jun Peng Ke-ji Chen |
| author_facet | Lin-zi Long Jian-feng Chu Hua Qu Qiao-ning Yang Yan Lu Chang-geng Fu Jun Peng Ke-ji Chen |
| author_sort | Lin-zi Long |
| collection | DOAJ |
| description | Abstract Background Numerous pre-clinical studies showed that Qingda granule (QDG) was effective in treating hypertension. This study aims to evaluate the efficacy and safety of QDG in reducing blood pressure among patients with grade 1 hypertension at low-medium risk. Methods The study is designed as a randomized, multi-center, double-blinded, non-inferiority clinical trial. Five hundred fifty-two patients with grade 1 hypertension at low-medium risk from 13 hospitals will be recruited and randomly assigned to the QDG group (n = 276, treated with valsartan capsule simulation agent and QDG) or control group (n = 276, treated with valsartan capsule and QDG simulation agent). The treatment period will be 4 weeks and the follow-up period will last 4 weeks after treatment. Primary outcome will be a decreased value of systolic blood pressure and diastolic blood pressure after treatment. And second outcome will include the decreased value of diastolic blood pressure and systolic blood pressure at the end of follow-up, the percentage of participants achieving normal blood pressure at the end of treatment and follow-up, the Hamilton Anxiety Scale and TCM syndrome scores at the end of treatment and follow-up, and levels of hypertensive hormones at end of treatment and follow-up. Discussion This study will provide initial evidence regarding the clinical efficacy and safety of QDG in treating grade 1 hypertension at low-medium risk. Trial registration Chinese Clinical Trial Registry ChiCTR2000033890 . Registered on 15 June 2020. |
| first_indexed | 2024-04-11T00:21:24Z |
| format | Article |
| id | doaj.art-fc69cf46e2a947e2b801b5ee3dfe9c2e |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T00:21:24Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-fc69cf46e2a947e2b801b5ee3dfe9c2e2023-01-08T12:20:12ZengBMCTrials1745-62152023-01-012411710.1186/s13063-022-07006-0Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trialLin-zi Long0Jian-feng Chu1Hua Qu2Qiao-ning Yang3Yan Lu4Chang-geng Fu5Jun Peng6Ke-ji Chen7Academy of Integrative Medicine, Fujian University of Traditional Chinese MedicineAcademy of Integrative Medicine, Fujian University of Traditional Chinese MedicineNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical SciencesNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical SciencesAcademy of Integrative Medicine, Fujian University of Traditional Chinese MedicineNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical SciencesAcademy of Integrative Medicine, Fujian University of Traditional Chinese MedicineNational Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical SciencesAbstract Background Numerous pre-clinical studies showed that Qingda granule (QDG) was effective in treating hypertension. This study aims to evaluate the efficacy and safety of QDG in reducing blood pressure among patients with grade 1 hypertension at low-medium risk. Methods The study is designed as a randomized, multi-center, double-blinded, non-inferiority clinical trial. Five hundred fifty-two patients with grade 1 hypertension at low-medium risk from 13 hospitals will be recruited and randomly assigned to the QDG group (n = 276, treated with valsartan capsule simulation agent and QDG) or control group (n = 276, treated with valsartan capsule and QDG simulation agent). The treatment period will be 4 weeks and the follow-up period will last 4 weeks after treatment. Primary outcome will be a decreased value of systolic blood pressure and diastolic blood pressure after treatment. And second outcome will include the decreased value of diastolic blood pressure and systolic blood pressure at the end of follow-up, the percentage of participants achieving normal blood pressure at the end of treatment and follow-up, the Hamilton Anxiety Scale and TCM syndrome scores at the end of treatment and follow-up, and levels of hypertensive hormones at end of treatment and follow-up. Discussion This study will provide initial evidence regarding the clinical efficacy and safety of QDG in treating grade 1 hypertension at low-medium risk. Trial registration Chinese Clinical Trial Registry ChiCTR2000033890 . Registered on 15 June 2020.https://doi.org/10.1186/s13063-022-07006-0HypertensionQingda granuleBlood pressureRandomized controlled trials |
| spellingShingle | Lin-zi Long Jian-feng Chu Hua Qu Qiao-ning Yang Yan Lu Chang-geng Fu Jun Peng Ke-ji Chen Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial Trials Hypertension Qingda granule Blood pressure Randomized controlled trials |
| title | Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial |
| title_full | Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial |
| title_fullStr | Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial |
| title_full_unstemmed | Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial |
| title_short | Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial |
| title_sort | effects of qingda granule on patients with grade 1 hypertension at low medium risk study protocol for a randomized controlled double blind clinical trial |
| topic | Hypertension Qingda granule Blood pressure Randomized controlled trials |
| url | https://doi.org/10.1186/s13063-022-07006-0 |
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