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

Abstract

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.

Keywords: Chinese herbal formula; Hongjing I granules; alternative medicine; clinical protocols; clinical trials; erectile dysfunction; traditional Chinese medicine.

Figure 1

Flow diagram.

Figure 2

SPIRIT schedule of tests and procedures 1. Demographic Data: Date of birth, height, weight. 2. Medical History: History of erectile dysfunction (ED), history of diabetes, history of cardiovascular diseases, history of other chronic diseases; surgical history, allergy history, medication history within the past 3 months; sexual history; participation in clinical trials within the past 3 months. 3. Physical Examination: Secondary sexual characteristics (skin, body shape, skeletal muscle development, Adam’s apple, beard, distribution and density of body hair, male breast development); reproductive system (penis size, presence of deformities or nodules, testicles); local sensory examination (sensation in the perineal area, cremasteric reflex). 4.Vital Signs: Respiration, body temperature, pulse, blood pressure. 5.Blood Routine: White blood cell count, percentage of neutrophils, percentage of lymphocytes, red blood cell count, hemoglobin, platelet count. Biochemical Analysis: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, indirect bilirubin, alkaline phosphatase, blood urea nitrogen (BUN), uric acid, blood glucose, creatinine. Urine Routine: Acidity, glucose, red blood cell count (microscopic examination), white blood cell count (microscopic examination), urine protein, ketones, urinary urobilinogen.

Figure 3

Packaging and appearance of Hongjing I granules (HJIG) and its placebo (a) HJIG and its placebo packaging (b) The appearance of HJIG granules and placebo granules (Left side is HJIG and right side is placebo granules).