Clinical evaluation of compound jinji granules in the treatment of primary premature ejaculation: a multicenter, randomized, double-blind, double-dummy, controlled trial
8 affiliations
- 1Xiyuan Hospital of Clinical Medical College of Beijing University of Chinese Medicine , ,
- 2Department of Andrology, Jiangsu Province Hospital of Chinese Medicine , ,
- 3Department of Andrology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine , ,
- 4Department of Andrology, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University , ,
- 5Department of Andrology, Jining Hospital of Integrated Traditional Chinese and Western Medicine , ,
- 6Department of Andrology, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine , ,
- 7Department of Andrology, Xiyuan Hospital of China Academy of Chinese Medical Sciences , ,
- 8Department of Urology, Peking University Third Hospital , ,
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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BibTeX
@article{ma2026clinical,
title = {{Clinical evaluation of compound jinji granules in the treatment of primary premature ejaculation: a multicenter, randomized, double-blind, double-dummy, controlled trial}},
author = {Dongyue Ma and Yun Chen and Chongfu Zhong and Qiang Han and Yong Wang and Feng Zhao and Hao Wang and Guanchao Du and Wenxiao Yu and Jun Guo and Fu Wang and Boda Guo},
journal = {Frontiers in pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1740832},
url = {https://europepmc.org/article/PMC/PMC13669152},
note = {CC BY},
}
RIS
TY - JOUR
TI - Clinical evaluation of compound jinji granules in the treatment of primary premature ejaculation: a multicenter, randomized, double-blind, double-dummy, controlled trial
AU - Dongyue Ma
AU - Yun Chen
AU - Chongfu Zhong
AU - Qiang Han
AU - Yong Wang
AU - Feng Zhao
AU - Hao Wang
AU - Guanchao Du
AU - Wenxiao Yu
AU - Jun Guo
AU - Fu Wang
AU - Boda Guo
PY - 2026
DA - 2026/10/01
JO - Frontiers in pharmacology
DO - 10.3389/fphar.2026.1740832
UR - https://europepmc.org/article/PMC/PMC13669152
AB - 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.
SN - 1663-9812
ER -