Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial
BackgroundHJIG is a potential treatment for erectile dysfunction (ED) that has been used in China for over 20 years. We conducted a multi-center, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of the Chinese Herbal Medicine, Hongjing I granule (HJIG), in...
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Frontiers Media S.A.
2024-12-01
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| author | Run-Nan Xu Run-Nan Xu Jun Guo Chun-He Zhang Qing Zhou Qiang Gen Qiang Gen Fu Wang Yu Zhao Yu Zhao Xin-Yun Luo Yan-Feng Li Yi-Jia Fu Yi-Jia Fu Xin Zhang Xin Zhang Wen-Zhi Wang Jian-Xiong Ma Jian Wang Jian Wang Xiao-Jun Huang Wen-Jie Huang Bo-Dong Lv Bo-Dong Lv |
| author_facet | Run-Nan Xu Run-Nan Xu Jun Guo Chun-He Zhang Qing Zhou Qiang Gen Qiang Gen Fu Wang Yu Zhao Yu Zhao Xin-Yun Luo Yan-Feng Li Yi-Jia Fu Yi-Jia Fu Xin Zhang Xin Zhang Wen-Zhi Wang Jian-Xiong Ma Jian Wang Jian Wang Xiao-Jun Huang Wen-Jie Huang Bo-Dong Lv Bo-Dong Lv |
| author_sort | Run-Nan Xu |
| collection | DOAJ |
| description | BackgroundHJIG is a potential treatment for erectile dysfunction (ED) that has been used in China for over 20 years. We conducted a multi-center, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of the Chinese Herbal Medicine, Hongjing I granule (HJIG), in patients with mild to moderate erectile dysfunction (ED).MethodsThis study is structured as a randomized, double-blind, placebo-controlled trial, executed across multiple centers. The recruitment strategy is primarily oriented towards patients demonstrating a pronounced preference for solely leveraging traditional Chinese medicine (TCM) interventions, a preference that is widely observed within TCM healthcare settings. A total of 100 patients, presenting with mild to moderate ED, specifically linked to the traditional diagnostic criteria of qi deficiency and blood stasis, will be enrolled. These participants will be randomly distributed between the HJIG (N = 50) and placebo (N = 50) arms. The designated treatment period is set at 8 weeks. Primary outcome measures encompass the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, the Sexual Encounter Profile (SEP), and scores derived from the traditional Chinese medicine symptom evaluation.ResultsOf the 122 men enrolled, the baseline IIEF-EF score averaged 16.00 [IQR: 13.00, 18.00]. Eight weeks post-randomization, the HJIG group demonstrated a mean change in IIEF-EF scores of 7.80 (±3.25), compared to 3.33 (±3.90) in the placebo group, signifying a marked difference (P < 0.001). The median alterations in SEP3 scores were 0.50 [IQR: 0.36, 0.75] for the HJIG group and 0.50 [0.20, 0.67] for the placebo group, revealing a statistically relevant distinction (P = 0.05). In both primary outcomes, HJIG proved superior to the placebo. Additionally, improvements in TCM symptom scores were notably greater in the HJIG group relative to the placebo, with no adverse events reported across both groups.ConclusionThe Hongjing I granule significantly improved symptoms in patients with mild to moderate ED. However, to validate these findings, further extended randomized trials are warranted.Clinical Trial RegistrationThe study has been registered in the Chinese Clinical Trial Registry (ChiCTR) and the registration number was ChiCTR2000041127. |
| format | Article |
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| publishDate | 2024-12-01 |
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| spelling | doaj-art-2b024b3f73f34e3ca123e7d26017ba712025-08-20T02:00:06ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122024-12-011510.3389/fphar.2024.13678121367812Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trialRun-Nan Xu0Run-Nan Xu1Jun Guo2Chun-He Zhang3Qing Zhou4Qiang Gen5Qiang Gen6Fu Wang7Yu Zhao8Yu Zhao9Xin-Yun Luo10Yan-Feng Li11Yi-Jia Fu12Yi-Jia Fu13Xin Zhang14Xin Zhang15Wen-Zhi Wang16Jian-Xiong Ma17Jian Wang18Jian Wang19Xiao-Jun Huang20Wen-Jie Huang21Bo-Dong Lv22Bo-Dong Lv23Department of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaKey Laboratory of Integrative Chinese and Western Medicine for Prevention and Treatment of Sexual Dysfunction of Zhejiang Province, Hangzhou, ChinaDepartment of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Urology and Andrology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, ChinaDepartment of Andrology, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Andrology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaDepartment of Andrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Andrology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaDepartment of Andrology, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha, ChinaDepartment of Urology and Andrology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, ChinaDepartment of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaKey Laboratory of Integrative Chinese and Western Medicine for Prevention and Treatment of Sexual Dysfunction of Zhejiang Province, Hangzhou, ChinaDepartment of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaKey Laboratory of Integrative Chinese and Western Medicine for Prevention and Treatment of Sexual Dysfunction of Zhejiang Province, Hangzhou, ChinaDepartment of Urology and Andrology, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, ChinaDepartment of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaDepartment of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaKey Laboratory of Integrative Chinese and Western Medicine for Prevention and Treatment of Sexual Dysfunction of Zhejiang Province, Hangzhou, ChinaDepartment of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaDepartment of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaDepartment of Urology, School of Medicine, The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaKey Laboratory of Integrative Chinese and Western Medicine for Prevention and Treatment of Sexual Dysfunction of Zhejiang Province, Hangzhou, ChinaBackgroundHJIG is a potential treatment for erectile dysfunction (ED) that has been used in China for over 20 years. We conducted a multi-center, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of the Chinese Herbal Medicine, Hongjing I granule (HJIG), in patients with mild to moderate erectile dysfunction (ED).MethodsThis study is structured as a randomized, double-blind, placebo-controlled trial, executed across multiple centers. The recruitment strategy is primarily oriented towards patients demonstrating a pronounced preference for solely leveraging traditional Chinese medicine (TCM) interventions, a preference that is widely observed within TCM healthcare settings. A total of 100 patients, presenting with mild to moderate ED, specifically linked to the traditional diagnostic criteria of qi deficiency and blood stasis, will be enrolled. These participants will be randomly distributed between the HJIG (N = 50) and placebo (N = 50) arms. The designated treatment period is set at 8 weeks. Primary outcome measures encompass the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, the Sexual Encounter Profile (SEP), and scores derived from the traditional Chinese medicine symptom evaluation.ResultsOf the 122 men enrolled, the baseline IIEF-EF score averaged 16.00 [IQR: 13.00, 18.00]. Eight weeks post-randomization, the HJIG group demonstrated a mean change in IIEF-EF scores of 7.80 (±3.25), compared to 3.33 (±3.90) in the placebo group, signifying a marked difference (P < 0.001). The median alterations in SEP3 scores were 0.50 [IQR: 0.36, 0.75] for the HJIG group and 0.50 [0.20, 0.67] for the placebo group, revealing a statistically relevant distinction (P = 0.05). In both primary outcomes, HJIG proved superior to the placebo. Additionally, improvements in TCM symptom scores were notably greater in the HJIG group relative to the placebo, with no adverse events reported across both groups.ConclusionThe Hongjing I granule significantly improved symptoms in patients with mild to moderate ED. However, to validate these findings, further extended randomized trials are warranted.Clinical Trial RegistrationThe study has been registered in the Chinese Clinical Trial Registry (ChiCTR) and the registration number was ChiCTR2000041127.https://www.frontiersin.org/articles/10.3389/fphar.2024.1367812/fullChinese herbal formularandomized control trialHongjing I granuleerectile dysfunctiontraditional Chinese medicine (TCM) |
| spellingShingle | Run-Nan Xu Run-Nan Xu Jun Guo Chun-He Zhang Qing Zhou Qiang Gen Qiang Gen Fu Wang Yu Zhao Yu Zhao Xin-Yun Luo Yan-Feng Li Yi-Jia Fu Yi-Jia Fu Xin Zhang Xin Zhang Wen-Zhi Wang Jian-Xiong Ma Jian Wang Jian Wang Xiao-Jun Huang Wen-Jie Huang Bo-Dong Lv Bo-Dong Lv Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial Frontiers in Pharmacology Chinese herbal formula randomized control trial Hongjing I granule erectile dysfunction traditional Chinese medicine (TCM) |
| title | Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial |
| title_full | Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial |
| title_fullStr | Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial |
| title_full_unstemmed | Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial |
| title_short | Efficacy of Hongjing I granule, an herbal medicine, in patients with mild to moderate erectile dysfunction in a randomized controlled trial |
| title_sort | efficacy of hongjing i granule an herbal medicine in patients with mild to moderate erectile dysfunction in a randomized controlled trial |
| topic | Chinese herbal formula randomized control trial Hongjing I granule erectile dysfunction traditional Chinese medicine (TCM) |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1367812/full |
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