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A multi-center randomized controlled clinical study of HIFU combined with Guizhi Poria Capsule in sequential treatment of uterine fibroids

A multi-center randomized controlled clinical study of HIFU combined with Guizhi Poria Capsule in sequential treatment of uterine fibroids

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005040
Enrollment
Unknown
Registered
2021-07-07
Start date
2021-06-15
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intramural uterine fibroids, IUF

Interventions

Sponsors

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 49 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20 to 49 years, regular menstrual cycle, 21-35 days; 2. Those who meet the IUF diagnostic criteria and the diameter of fibroids is =3cm; 3. Those who meet the conditions of HIFU treatment and receive HIFU treatment; 4. Those who have no requirement for childbirth during treatment; 5. Subjects gave informed consent and signed an informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to the relevant drug ingredients in this study; 2. Patients with severe primary diseases and mental illnesses such as severe heart, cerebrovascular, liver, kidney and hematopoietic system, diabetes, and thyroid diseases; 3. Submucosal fibroids, subserosal fibroids, adenomyosis, adenomyoma, and malignant transformation; 4. Those who have participated in other clinical researches within the past month, or are using similar drugs and related treatments within one month, and the efficacy of the drugs is difficult to judge; 5. The investigator believes that it is not suitable to participate in this clinical research.

Design outcomes

Primary

MeasureTime frame
Uterine size;Chinese Medicine syndrome score;Uterine fibroids size;

Secondary

MeasureTime frame
Uterine Fibroids Symptoms and Health-Related Quality of Life Questionnaire;

Countries

China

Contacts

Public ContactHuang Yefang

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

22654233@qq.com+86 13880490461

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026