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A multi-center, randomized, double-blind controlled clinical study of Yuzhi Zhixue Granules and tranexamic acid in the treatment of abnormal uterine bleeding

A multi-center, randomized, double-blind controlled clinical study of Yuzhi Zhixue Granules and tranexamic acid in the treatment of abnormal uterine bleeding

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059418
Enrollment
Unknown
Registered
2022-04-29
Start date
2022-04-28
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

abnormal uterine bleeding

Interventions

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Meet AUB-E or AUB-O diagnostic criteria: (1) Age 18-55 years; (2) Non-acute severe bleeding; (3) Patients who meet the diagnostic criteria of abnormal uterine bleeding Western medicine (including periodic regularity with idiopathic menorrhagia, the diagnostic criteria of menorrhagia adopt the menstrual blood loss figure Pictorial Blood Loss Assessment Chart (PBAC) proposed by Higham JM in 1990 to evaluate the menstrual flow, two Menstrual flow > 100 points in the next menstrual cycle is diagnosed as menorrhagia); 2. The standard of syndrome differentiation of excess heat syndrome of traditional Chinese medicine is drawn up with reference to the relevant contents of the planned textbook "Gynecology of traditional Chinese Medicine" (edited by Tan Yong, China traditional Chinese Medicine Publishing House, 10th Edition): (1) Main symptoms: 1) Menstrual blood falls out of time, or drips and increases from time to time; 2) The color is dark red or bright red, the texture is thick, or there are blood clots; (2) Secondary symptoms: 1) Red lips and red eyes, hot and thirsty; 2) dry stool; 3) The color of urine is yellow; (3) Tongue pulse: red tongue, yellow tongue coating, slippery and rapid pulse; The above main symptoms are necessary, and the secondary symptoms have one or more items, combined with the tongue and pulse, the syndrome can be differentiated as the original syndrome; 3. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant, preparing to become pregnant, or breastfeeding; 2. Those who have used hormone drugs within 3 months before treatment; 3. Combined with malignant tumor, severe endometriosis, submucosal fibroids and other organic lesions; 4. Patients with serious primary diseases such as serious heart, liver, kidney function and blood system; 5. Those who cannot take effective contraceptive measures during the test and within one month after the end of the test; 6. Bleeding due to contraceptives, intrauterine devices, inflammation, and other systemic diseases that can cause gynecological bleeding; 7. Patients who stop bleeding within 4 days after diagnostic curettage; 8. Patients with abnormal coagulation function; 9. Patients who are allergic to Yuzhi Zhixue Granules and tranexamic acid; 10. The mentally ill; 11. Hemoglobin is lower than 75 g/L; 12. Patients who have participated in other clinical trials within 12 or 3 months; 13. Suspected or real history of alcohol or drug abuse, or other diseases or conditions that reduce the possibility of enrolling or complicate enrollment, such as frequent changes in the working environment and other conditions that are likely to cause loss to follow-up, according to the investigator's judgment; 14. Patients with thrombosis tendency.

Design outcomes

Primary

MeasureTime frame
bleeding;bleeding duration;hemoglobin;prothrombin time;changes in endometrial thickness;

Countries

China

Contacts

Public ContactYang Xin

Lunan Hope Pharmaceutical CO.,LTD

xinyang_2003@sina.com+86 13701318932

Outcome results

None listed

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