Efficacy of the Hongjing I granule herbal formulation in treating mild to moderate erectile dysfunction: A multicentre, randomized, double-blind, placebo-controlled clinical trial protocol

Abstract Background Erectile dysfunction (ED) is a common disease in male urology, and there is a single class of drugs used for its first-line treatment. Approximately 20% of patients do not experience improvement in overall sexual satisfaction (OS) after taking tadalafil. Currently, traditional Chinese medicine (TCM) is widely used as a complementary and alternative medicine (CAM) approach for ED patients. The Hongjing I granule (HJIG) herbal formula has shown good therapeutic effects on ED in preclinical studies. However, further evidence is needed to demonstrate its clinical efficacy and safety.Methods This study is a randomized, double-blind, placebo-controlled multicentre trial. 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 This study is the first multicentre study to compare traditional Chinese herbal formulas with placebos in the treatment of ED. It aims to verify the improvement of TCM syndrome differentiation, erectile function, and sexual experience and to further broaden the treatment options for ED. The hypothesis is that HJIG can improve the erectile function score and sexual experiences of patients diagnosed with qi deficiency and blood stasis–type mild to moderate ED. This study may establish a new treatment for ED, distinct from other drugs used for similar clinical indications in clinical practice, and may provide high-quality reference evidence for its use as a complementary or substitute drug.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000041127.