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Efficacy and safety of Heyan Danggui Yixue oral Liquid in the treatment of abnormal uterine bleeding with anemia in Qi and blood deficiency syndrome

Efficacy and safety of Heyan Danggui Yixue oral Liquid in the treatment of abnormal uterine bleeding with anemia in Qi and blood deficiency syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086279
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

abnormal uterine bleeding with anemia

Interventions

control group:conventional therapy
treatment group:Conventional treatment combined with Danggui Yixue oral liquid

Sponsors

The first hospital of Hebei medical university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-55 years old with 80g/L < hemoglobin < 110g/L; 2. Meet the diagnostic criteria for abnormal uterine bleeding; 3. Meet the diagnostic criteria of Qi deficiency syndrome or blood deficiency syndrome; 4. Informed consent, voluntary acceptance of the treatment plan of this study and regular follow-up;

Exclusion criteria

Exclusion criteria: 1.BMI>28kg/m2; 2.D-Dimer>500µg/L; 3.Preparing for pregnancy, pregnancy, postmenopausal or breastfeeding women; 4.Acute abnormal uterine bleeding, AUB requiring urgent treatment to prevent further blood loss; 5.Have a history of hypertension or diabetes that is not currently under effective control; 6.Have a history of organic lesions causing uterine bleeding, Such as genital infection (acute or chronic endometritis, myositis, etc.), genital benign/malignant tumors (ovarian cysts, single uterine fibroids >4cm, uterine sarcoma, endometrial atypical hyperplasia and malignancies, cervical cancer, etc.) and others (endometriosis stage III or IV, adenomyosis, etc.), genital injury (vaginal laceration bleeding, etc.); 7.Anemia caused by abnormal hematopoietic stem cells/progenitors (such as aplastic anemia, pure red cell aplastic anemia, congenital dyserythropoietic anemia, hematopoietic system malignant cloning diseases, etc.), anemia caused by abnormal hematopoietic regulation (such as anemia caused by bone marrow stromal cell damage, anemia caused by hyperlymphocytic anemia, and anemia caused by abnormal levels of hematopoietic regulatory factors Anemia caused by hyperapoptosis of blood and hematopoietic cells), excessive red blood cell destruction anemia (i.e., hemolytic anemia, thalassemia), etc.; 8.Have a history coagulation disorders, such as platelet disorders (e.g., thrombocytopathenia, thrombocytopenia), coagulation disorders (e.g., hemophilia), complex hemostatic mechanism disorders (e.g., disseminated intravascular coagulation), vascular wall disorders (e.g., hereditary hemorrhagic telangiectasia, Cushing syndrome), etc.; 9.Latrogenic abnormal uterine bleeding, such as use of sex hormones, GnRH-a, placement of Iuds or use of anticoagulants; 10.Have a history of subcutaneous contraceptive implants, progesterone intrauterine release devices and other treatment methods are still valid; 11.Prior history of other contraindications as defined in the EuxIL ® and Dapotone ® instructions, such as arterial thrombotic disease (cerebrovascular accident, myocardial infarction), prethrombotic symptoms (such as angina pectoris and transient ischemic attacks), or prior medical history; Known predisposition to venous or arterial thrombosis, such as activated protein (APC) resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and antiphospholipid antibodies; Hypoadrenal function; Known or suspected progestogen-dependent tumors; Known or suspected sex hormone-related malignancies; Diseases or symptoms aggravated by the use of sex hormones, such as severe pruritus, obstructive jaundice, herpes during pregnancy, porphyria and otosclerosis; 12.Combined with thyroid disease and TSH outside the normal reference range; 13.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 1.5 times the upper limit of normal reference value, or serum creatinine (Scr)> the upper limit of normal reference value; 14.With severe or malignant diseases of cardiovascular and cerebrovascular, liver, kidney, hematopoietic or other systems; 15.Allergic to the experimental drug; 16.Patients who have participated in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
hemoglobin;

Secondary

MeasureTime frame
TCM symptom score;blood routine examination;menstruation;Dysmenorrhea VAS score;

Countries

China

Contacts

Public ContactLi Xiaodong

The first hospital of Hebei medical university

lixiaodong@hebmu.edu.cn+86 186 3388 9278

Outcome results

None listed

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