The efficacy of GnRH-a followed by SanJieZhenTong capsules in long-term management of endometriosis: Study protocol for a multicenter, double-blinded, double-dummy randomized clinical trial

Yunxi Zheng, Ruoyi Guo, R. J. Guo, Qi Tian, Yan Du, Li Wang, Zhiling Zhu, Erkai Yu, Jing Sun, Xiaofang Yi, Congjian Xu
Contemporary clinical trials communications · 2023 · vol. 34 , pp. 101179 · doi:10.1016/j.conctc.2023.101179 · PMID:37409188 · W4381332491
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⚙ AI-generated summary by claude@2026-06, 2026-06-07 ⓘ

This randomized trial will assess if SanJieZhenTong Capsules are effective for long-term endometriosis management after GnRH-a treatment, comparing recurrence rates to oral contraceptives.

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Abstract

Background: Endometriosis is a common benign gynecological disorder with high risk of recurrence and adverse impact on fertility-sparing. This study aims to evaluate the effectiveness and safety of SanJieZhenTong Capsules, a traditional Chinese medicine, in the long-term management of endometriosis postoperatively. Methods: and analysis: A prospective, double-blinded, double-dummy parallel-group randomized controlled trial will be conducted at three university-based medical centers in China. A total of 600 patients with rAFS III-IV endometriosis diagnosed by laparoscopy will be enrolled. After fundamental treatment (gonadotropin-releasing hormone agonists injection starts on the first day of menstruation postoperatively, and repeats 3 times every 28 days), participants will be randomly allocated to the oral contraceptive group (oral contraceptive + dummy A) or SanJieZhenTong Capsules group (SanJieZhenTong Capsules + dummy B) in a 1:1 ratio. All participants will be treated and followed up for 52 weeks. The primary outcome is a recurrence rate based on endometriosis-related symptoms, physical examination, and/or ultrasound/MRI findings. The secondary outcome includes changes in quality of life and organic function outcome via the 36-item Short-Form scores and gastrointestinal function score. Conclusion: The current trial could provide rigorous evidence on SanJieZhenTong Capsules application in the long-term management of advanced-stage endometriosis.

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endometriosis

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