Efficacy and safety evaluation of Xiaozheng pill in the treatment of Uterine leiomyoma: a prospective and positive controlled clinical study

Phase 4

• Conditions: terine leiomyoma

• Registration Number: ITMCTR2100005316
• Lead Sponsor: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Premenopausal women aged 18 = 45;
2.Patient is willing to receive drug treatment, and there is no indication of hysteromyoma surgery;
3.Uterine leiomyoma leads to menorrhagia (= 80 ml), anemia and compression symptoms, which can meet one of them. Surgical treatment or surgical treatment is refused. Moderate and severe anemia should be included in the group after anemia improvement (HB = 90 g / L);
4.FSH< 25 mIU/mL;
5.The subjects voluntarily participated in the clinical trial and signed the informed consent form.

Exclusion Criteria

1.Pregnant, menopausal and lactating women and those who are ready to give birth during medication or within 3 months after cessation;
2.Submucosal hysteromyoma;
3.Patients with endometriosis or adenomyosis;
4.Patients who have used gongliuxiao, gongliuning, gongliuqing, Hongjin Xiaojie, Rupi Anxiao and other proprietary Chinese medicines for the treatment of hysteromyoma in recent 1 month;
5.Patients who are using contraceptives or taking hormone drugs within 1 month;
6.Complicated with severe vaginitis, pelvic inflammation, malignant tumor and other diseases; Patients with serious primary diseases such as cardiovascular, cerebrovascular and hematopoietic systems, psychosis and dementia;
7.Poor compliance, unable to cooperate or fail to use drugs according to regulations, and unable to determine the clinical efficacy;
8.Participated in other clinical trials within 1 month before participating in this study;
9.Allergic constitution or allergic to the test drugs and components;
10.Patients with severe liver and kidney diseases and adrenocortical insufficiency, and / or ALT and AST > twice the upper limit of normal value, bun and Cr > the upper limit of normal value;
11.Other patients who are not suitable to participate in the clinical trial according to the opinions of the researchers, including the current physical or psychological conditions that make them unable to comply with the protocol.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of uterine fibroids;