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Clinical trial of Guizhi Fuling capsule in the prevention and treatment of pelvic inflammatory disease

Guizhi Fuling capsule for the prevention and treatment of pelvic inflammatory disease sequelae (blood stasis syndrome) a randomized double-blind placebo-controlled multi-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000398
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-09-16
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Sequelae of pelvic inflammatory disease

Interventions

Control Group:Guizhi Fuling capsule simulator was taken for 12 weeks
Test group:Guizhi Fuling capsule was taken for 12 weeks

Sponsors

The Third Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) According to the diagnostic criteria of Western medicine for sequelae of pelvic inflammatory disease(2)according to the criteria of TCM syndrome differentiation of blood stasis (3)The VAS score of abdominal pain =3 or recurrent attack of previous PID (4)The age ranged from 20 to 50 years (5)21 days = menstrual cycle =35 days (6)The patient gave informed consent and signed the informed consent form

Exclusion criteria

Exclusion criteria: (1)Pelvic inflammatory disease (2) Gynecological tumors (uterine leiomyoma larger than 4 cm in diameter and submucosal leiomyoma) and other related symptoms (3) Ovulation disorders (polycystic ovary syndrome premature ovarian insufficiency congenital gonadal hypoplasia functional ovarian tumor etc.) cervical and uterine body factors (cervical incompetence endometrial lesions uterine tumors uterine adhesions Adenomyosis etc.) (4) Infertility due to non-pelvic inflammatory diseases such as endometriosis and complete obstruction of the fallopian tube (5) Patients with severe primary diseases of heart brain liver kidney hematopoiesis and immune system and psychosis alanine aminotransferase (Alt) aspartate aminotransferase (AST) were more than 2 times of the upper limit of the normal value serum creatinine (CR) were more than the upper limit of the normal value (6)Anaphylaxis was defined as people who were allergic to three or more foods (7) Participated in other clinical studies within 1 month before screening (8)Were not considered suitable by the investigators to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Changes in VAS scores of lower abdominal pain;PID recurrence rate;

Secondary

MeasureTime frame
Time to first recurrence of PID;Pregnancy rate;Pelvic inflammatory masses effusion improvement rate;Blood stasis syndrome effective rate;The change of pelvic sign grading score;

Countries

China

Contacts

Public ContactRong Li

The Third Hospital of Peking University

wangbearyang@163.com13701085402

Outcome results

None listed

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