Clinical evaluation of compound jinji granules in the treatment of primary premature ejaculation: a multicenter, randomized, double-blind, double-dummy, controlled trial

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Abstract
Background: Primary premature ejaculation (PPE) affects men’s sexual confidence, impairs couple relationships, and may lead to anxiety and depression. Compound Jinji Granule (CJG) is a traditional Chinese medicine (TCM) formula for treating PPE. Preliminary rat experiments suggested its potential in delaying ejaculation, and this study aims to further validate its clinical efficacy. Methods: This multicenter, double-blind, double-dummy, randomized controlled non-inferiority trial enrolled patients with PPE diagnosed with liver depression and kidney deficiency pattern. Participants were randomly assigned to an experimental group or a control group for 4 weeks. The experimental group received CJG plus a placebo matching dapoxetine, while the control group received a placebo matching CJG plus dapoxetine. The primary outcome was the change in stopwatch-measured average intravaginal ejaculatory latency time (IELT) during treatment. Secondary outcomes included the premature ejaculation profile (PEP), TCM symptom score, degree of IELT improvement, and clinical global impression of change (CGI-C). Results: A total of 92 subjects were enrolled, with 7 dropouts (4 in the experimental group, 3 in the control group). After 4 weeks of treatment, the average IELT in the experimental group increased from 0.29 ± 0.12 min at baseline to 2.03 ± 0.83 min ( P < 0.01); in the control group, it increased from 0.34 ± 0.15 min to 2.48 ± 1.08 min ( P < 0.01). Both groups showed significant improvements across all PEP outcomes. TCM symptom scores improved significantly in both groups, with the experimental group showing superior improvement compared with the control group. The proportion of patients reporting at least mild improvement was significantly higher in the experimental group than in the control group (73.91% vs. 53.33%, P < 0.05). In addition, no significant between-group difference was observed in the proportion of patients achieving an increase in IELT of >1 min or >3 min ( P > 0.05). Adverse events in the experimental group included diarrhea (n = 1), abdominal bloating (n = 1), dry mouth (n = 1), and constipation (n = 1), while those in the control group included nausea (n = 4), headache (n = 3), and dizziness (n = 2). All adverse events in both groups were mild and well tolerated, and no serious adverse events were reported. Conclusion: CJG significantly prolongs IELT, improves ejaculatory control and sexual satisfaction, effectively alleviates ejaculation-related distress and couple communication, and demonstrates good safety.

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