A multicenter, randomized, double-blind, placebo/positive controlled clinical trial of the clinical efficacy and safety of Xiaojiean capsule in the treatment of uterine fibroids

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200005932

Enrollment

Unknown

Registered

2022-04-28

Start date

2022-08-01

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

uterine leiomyoma

Interventions

Control 1:Placebo capsule

Experimental :Xiaojiean capsule

Control 2:Hongjinxiaojie capsule

Eligibility

Sex/Gender

Female

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of uterine fibroids; (2) TCM syndrome differentiation is damp-heat stasis syndrome or qi stagnation and blood stasis syndrome; (3) 20= age =45 years, sexual history; (4) 2.5cm = maximum fibroid length = 5.0cm, and uterine volume =280 cm3 (about 10 weeks of gestation); ? Regular menstrual cycle 28±7 days; ? Signed informed consent voluntarily and conditionally followed up.

Exclusion criteria

Exclusion criteria: (1) Postmenopausal women; ? Pregnant women or lactation women; (3) those who have a birth plan within the last 6 months; (4) Use of Intrauterine Device (IUD) for contraception; ? Patients in critical condition; ? special fibroids: submucosal fibroids, pedicled subserous fibroids, cervical fibroids, etc. Complicated with adenomyosis, ovarian tumor, reproductive system malformation and other special organic diseases; ? abnormal laboratory indicators: Hemoglobin (Hb) <80g/L, platelet count (Plt) <50×109/L;??Serum creatinine (Scr) exceeds 3 times the upper limit of normal value.??Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase,??ALP and ?-glutamyl transferase (?-GT) were 5 times higher than the upper limit of normal value.Total bilirubin (TBiL) was 3 times higher than the upper limit of normal value. (9) Persons suffering from mental illness; (10) Participate in other clinical trials within 3 months; (11) allergic constitution, allergic to a variety of drugs or drugs used in this study;

Design outcomes

Primary

Measure	Time frame
Maximum rate of change in uterine fibroid volume;	—

Secondary

Measure	Time frame
Rate of change in uterine volume;The rate of change of menstrual blood volume;Ufs-qol score changes;	—

Countries

China

Contacts

Public ContactDu Huilan

duhuilan@163.com13931150880

Outcome results

None listed

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