PMID- 38034900
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231202
IS  - 1178-7074 (Print)
IS  - 1178-7074 (Electronic)
IS  - 1178-7074 (Linking)
VI  - 16
DP  - 2023
TI  - Efficacy of Chinese Herbal Medicine Formula in the Treatment of Mild to Moderate 
      Erectile Dysfunction: Study Protocol for a Multi-Center, Randomized, 
      Double-Blinded, Placebo-Controlled Clinical Trial.
PG  - 5501-5513
LID - 10.2147/IJGM.S436347 [doi]
AB  - INTRODUCTION: Erectile dysfunction (ED) is a prevalent condition in urology, 
      primarily managed with PDE5 inhibitors (PDE5Is). However, approximately 20% of 
      patients do not experience improvement in overall sexual satisfaction (OS) after 
      taking PDE5Is. Among these, traditional Chinese medicine (TCM) has emerged as a 
      complementary approach, with formulas like Hongjing I granules (HJIG) showing 
      promise in preliminary studies. This study aims to rigorously evaluate the 
      effectiveness and safety of HJIG in mild to moderate ED cases, assessing 
      improvement in both sexual function and TCM pattern alignment. METHODS: This 
      study is a randomized, double-blind, placebo-controlled multicentre trial. 
      Recruitment will be conducted from patients who have a strong willingness to try 
      using only traditional Chinese medicine treatment (This is very common in 
      traditional Chinese medicine hospitals.). A total of 100 patients diagnosed with 
      mild to moderate ED caused by qi deficiency and blood stasis will be recruited 
      and randomly assigned to receive one of two treatments: HJIG (N = 50) or placebo 
      (N = 50). Patients will receive 8 weeks of treatment and a 16-week follow-up 
      starting from the fourth week of treatment. Outcome measures, including the 
      International Index of Erectile Function-Erectile Function domain (IIEF-EF) 
      score, Sexual Encounter Profile (SEP), and Traditional Chinese Medicine symptom 
      score, will be evaluated. DISCUSSION: The expected outcome of this trial is that 
      the use of the herbal formula HIJG alone can improve overall sexual satisfaction 
      (OS) in patients with mild to moderate ED, while also improving their traditional 
      Chinese medicine symptom scores. This will provide evidence-based support for the 
      use of Chinese medicine in the treatment of ED in China. TRIAL REGISTRATION: 
      Chinese Clinical Trial Registry, ChiCTR2000041127, Registered on 19 December 
      2020, https://www.chictr.org.cn/showproj.html?proj=46469. TRIAL STATUS: 
      Recruitment began in March 2021, therefore 80 patients have been recruited. It is 
      expected to finish recruiting in December 2023.
CI  - (c) 2023 Xu et al.
FAU - Xu, Run-Nan
AU  - Xu RN
AUID- ORCID: 0009-0009-3270-0988
AD  - The Second Affiliated Clinical Medical College, Zhejiang Chinese Medical 
      University, Hangzhou, Zhejiang, People's Republic of China.
FAU - Ma, Jian-Xiong
AU  - Ma JX
AD  - Department of Urology, School of Medicine, The Second Affiliated Hospital, 
      Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.
FAU - Zhang, Xin
AU  - Zhang X
AUID- ORCID: 0009-0004-0120-1813
AD  - The Second Affiliated Clinical Medical College, Zhejiang Chinese Medical 
      University, Hangzhou, Zhejiang, People's Republic of China.
FAU - Liao, Ze-Dong
AU  - Liao ZD
AD  - Department of Urology, School of Medicine, The Second Affiliated Hospital, 
      Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.
FAU - Fu, Yi-Jia
AU  - Fu YJ
AD  - The Second Affiliated Clinical Medical College, Zhejiang Chinese Medical 
      University, Hangzhou, Zhejiang, People's Republic of China.
FAU - Lv, Bo-Dong
AU  - Lv BD
AD  - Department of Urology, School of Medicine, The Second Affiliated Hospital, 
      Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20231124
PL  - New Zealand
TA  - Int J Gen Med
JT  - International journal of general medicine
JID - 101515487
PMC - PMC10683653
OTO - NOTNLM
OT  - Chinese herbal formula
OT  - Hongjing I granules
OT  - alternative medicine
OT  - clinical protocols
OT  - clinical trials
OT  - erectile dysfunction
OT  - traditional Chinese medicine
COIS- The authors report no conflicts of interest in this work.
EDAT- 2023/11/30 18:45
MHDA- 2023/11/30 18:46
PMCR- 2023/11/24
CRDT- 2023/11/30 17:40
PHST- 2023/08/30 00:00 [received]
PHST- 2023/11/10 00:00 [accepted]
PHST- 2023/11/30 18:46 [medline]
PHST- 2023/11/30 18:45 [pubmed]
PHST- 2023/11/30 17:40 [entrez]
PHST- 2023/11/24 00:00 [pmc-release]
AID - 436347 [pii]
AID - 10.2147/IJGM.S436347 [doi]
PST - epublish
SO  - Int J Gen Med. 2023 Nov 24;16:5501-5513. doi: 10.2147/IJGM.S436347. eCollection 
      2023.