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; Qi Tian; Yan Du; Li Wang; Zhiling Zhu; Erkai Yu; Jing Sun; Xiaofang Yi; Congjian Xu

Contemporary Clinical Trials Communications (Aug 2023)

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,
Qi Tian,
Yan Du,
Li Wang,
Zhiling Zhu,
Erkai Yu,
Jing Sun,
Xiaofang Yi,
Congjian Xu

Affiliations

Yunxi Zheng: Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China; Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China; Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China
Ruoyi Guo: Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China; Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China; Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China; Department of Integrated Traditional & Western Medicine, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China
Qi Tian: Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China; Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China; Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China
Yan Du: Office of Clinical Epidemiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
Li Wang: Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China; Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China; Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China; Department of Integrated Traditional & Western Medicine, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China
Zhiling Zhu: Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China; Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China; Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China; Department of Integrated Traditional & Western Medicine, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China
Erkai Yu: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200011, PR China
Jing Sun: Department of Obstetrics and Gynecology, Shanghai First Maternity and Infant Hospital, Shanghai, 200011, PR China; Corresponding author. Department of Obstetrics and Gynecology, Shanghai First Maternity and Infant Hospital, Shanghai, 200011, PR China.
Xiaofang Yi: Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China; Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China; Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China; Corresponding author. Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China.
Congjian Xu: Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China; Department of Obstetrics and Gynecology, Shanghai Medical School, Fudan University, Shanghai, 200011, China; Department of Gynecology, Shanghai Key Laboratory of Female Reproductive Endocrine-Related Diseases, Shanghai, 200011, China; Corresponding author. Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, 200011, China.

Journal volume & issue: Vol. 34
p. 101179

Abstract

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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.

Published in Contemporary Clinical Trials Communications

ISSN: 2451-8654 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Medicine (General)
Website: https://www.journals.elsevier.com/contemporary-clinical-trials-communications/

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